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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002529-21 | EudraCT Number |
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The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QMF149 150/160 µg | Experimental | QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered once daily (o.d) via Concept1 inhaler in the evening. |
|
| QMF149 150/320 µg | Experimental | QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening. |
|
| MF 400 µg | Active Comparator | Mometasone furoate (MF) 400 μg was delivered o.d via Twisthaler® in the evening |
|
| Salmeterol /fluticasone 50/500 μg | Active Comparator | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
| MF 800 μg | Active Comparator | MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol acetate/Mometasone furoate | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26 | Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52 | The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions. |
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Inclusion Criteria:
Spacer devices are permitted for reversibility testing only.
-Participants who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All participants must perform a reversibility test at Visit 101
If reversibility is not demonstrated at Visit 101:
Exclusion Criteria:
Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the participant fails the repeat assessment, the participant may be rescreened once
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35244 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36472162 | Derived | Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. | |
| 34452934 |
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3890 participants were screened of which 2216 were randomized to 1 of the 5 treatment groups with a randomization ratio of 1:1:1:1:1.
Participants took part in 316 investigative sites in 24 countries from 29 Dec 2015 to 28 Jun 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | QMF149 150/320 μg | QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered once daily (o.d.) via Concept1 inhaler in the evening. |
| FG001 | QMF149 150/160 μg | QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2018 | Dec 11, 2019 |
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| Mometasone furoate |
| Drug |
|
| Salmeterol xinafoate/fluticasone propionate | Drug |
|
| Weeks 4, 12, 26 and 52 |
| Trough FEV1 at Week 52 | Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | Week 52 |
| Pre-dose FEV1 at Weeks 4 and 12 | Pre-dose trough FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | Weeks 4 (Day 30) and 12 (Day 86) |
| Post Dose FEV1 (5 Minutes-1 Hour) | Post-dose FEV1 measurements were analyzed at 5 minutes, 15 minutes, 30 minutes and 1 hour. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | Up to Week 52 (Day 364) |
| Trough Forced Vital Capacity (FVC) | FVC is the total amount of air exhaled during the FEV test. Trough FVC is defined as average of the two FVC measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment. | Up to Week 52 (Day 365) |
| Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75) | FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment. | Up to Week 52 (Day 365) |
| Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment | PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose). At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used. | Up to Weeks 26 and 52 |
| Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52 | Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions | Weeks 26 (Day 183) and 52 (Day 364) |
| Change From Baseline in Percentage of Asthma Symptoms Free Days | All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms. | Up to Week 52 |
| Change Form Baseline in Percentage of Days With no Daytime Symptoms | All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems). | Up to Week 52 |
| Change From Baseline in Percentage of Nights With no Night-time Awakenings | All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems). | Up to Week 52 |
| Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening | All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for mornings with no symptoms on awakening was "Did you have asthma symptoms upon awakening in the morning?" to be answered with "None" with scores from 0 (no problem)-4 (very severe problems). | Up to Week 52 |
| Rescue Medication Usage | All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. The number of puffs of rescue medication during the past 12 hours is recorded twice (morning/evening) by the participant prior to taking study medication. The mean daily number of puffs of rescue medication use will be calculated for each participant, done separately for morning (night-time), evening (daytime), and daily (night-time plus daytime) rescue medication use | Up to Weeks 26 and 52 |
| Time to First Asthma Exacerbation by Exacerbation Category | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | Up to Week 52 |
| Time to First Hospitalization for Asthma Exacerbation | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | Up to Week 52 |
| Annual Rate of Asthma Exacerbations by Exacerbation Category | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | Up to Week 52 |
| Duration in Days of Asthma Exacerbations by Exacerbation Category | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | Up to Week 52 |
| Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | Up to Week 52 |
| Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | Up to Week 52 |
| Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations | Up to Week 52 |
| Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations | The treatment of asthma exacerbations including the initiation of systemic corticosteroids were done according to investigator's or treating physician's medical judgement and in line with national and international recommendations. If systemic corticosteroids were required, a participant could return to the study after successfully completing a taper of approximately 7-10 days. | Up to Week 52 |
| Change From Baseline in Percentage of Rescue Medication Free Days | All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. Rescue medication free days is defined as any day where the participant did not use any puffs of rescue medication during daytime and night-time. | Up to Weeks 26 and 52 |
| Asthma Quality of Life Questionnaire (AQLQ) | AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). It consists of 4 domains:
| Up to Week 52 (Day 364) |
| Trough FEV1 Measured After 26 Weeks of Treatment | Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | Week 26 |
| Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes | A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee. | Up to Week 52 |
| Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE is any untoward medical occurrence (i.e., any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. An SAE is defined as any adverse event (appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s) or medical conditions(s) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant, i.e. defined as an event that jeopardizes the participants or may require medical or surgical intervention. | Approximately up to 56 weeks |
| Los Angeles |
| California |
| 90025 |
| United States |
| Novartis Investigative Site | Orange | California | 92868 | United States |
| Novartis Investigative Site | Riverside | California | 92506 | United States |
| Novartis Investigative Site | San Diego | California | 92117 | United States |
| Novartis Investigative Site | San Jose | California | 95117 | United States |
| Novartis Investigative Site | Stockton | California | 95207 | United States |
| Novartis Investigative Site | Westminster | California | 92683 | United States |
| Novartis Investigative Site | Denver | Colorado | 80230 | United States |
| Novartis Investigative Site | Miami | Florida | 33144 | United States |
| Novartis Investigative Site | Tallahassee | Florida | 32308 | United States |
| Novartis Investigative Site | Winter Park | Florida | 32789 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21236 | United States |
| Novartis Investigative Site | Waldorf | Maryland | 20602 | United States |
| Novartis Investigative Site | North Dartmouth | Massachusetts | 02747-3322 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63141 | United States |
| Novartis Investigative Site | Bellevue | Nebraska | 68123 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89119 | United States |
| Novartis Investigative Site | Skillman | New Jersey | 08558 | United States |
| Novartis Investigative Site | Cortland | New York | 13045 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73120 | United States |
| Novartis Investigative Site | Tulsa | Oklahoma | 74136 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504 | United States |
| Novartis Investigative Site | Portland | Oregon | 97213 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Novartis Investigative Site | North Charleston | South Carolina | 29407 | United States |
| Novartis Investigative Site | Boerne | Texas | 78006 | United States |
| Novartis Investigative Site | El Paso | Texas | 79903 | United States |
| Novartis Investigative Site | Greenfield | Wisconsin | 53228 | United States |
| Novartis Investigative Site | Plovdiv | BGR | 4000 | Bulgaria |
| Novartis Investigative Site | Varna | BGR | 9000 | Bulgaria |
| Novartis Investigative Site | Vidin | BGR | 3703 | Bulgaria |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Plovdiv | 4002 | Bulgaria |
| Novartis Investigative Site | Rousse | 7002 | Bulgaria |
| Novartis Investigative Site | Sofia | 1407 | Bulgaria |
| Novartis Investigative Site | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Sofia | Bulgaria |
| Novartis Investigative Site | Stara Zagora | 6000 | Bulgaria |
| Novartis Investigative Site | Troyan Municipality | 5600 | Bulgaria |
| Novartis Investigative Site | Beijing | Beijing Municipality | 100044 | China |
| Novartis Investigative Site | Beijing | Beijing Municipality | 100730 | China |
| Novartis Investigative Site | Fuzhou | Fujian | 350025 | China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510120 | China |
| Novartis Investigative Site | Haikou | Hainan | 570311 | China |
| Novartis Investigative Site | Shijiazhuang | Hebei | 050000 | China |
| Novartis Investigative Site | Wuhan | Hubei | 430030 | China |
| Novartis Investigative Site | Changsha | Hunan | 410011 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210006 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210009 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210029 | China |
| Novartis Investigative Site | Suzhou | Jiangsu | 215006 | China |
| Novartis Investigative Site | Changchun | Jilin | 130021 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110000 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110003 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110011 | China |
| Novartis Investigative Site | Shanghai | Shanghai Municipality | 200032 | China |
| Novartis Investigative Site | Xian | Shanxi | 710061 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310006 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310014 | China |
| Novartis Investigative Site | Beijing | 100029 | China |
| Novartis Investigative Site | Beijing | 100191 | China |
| Novartis Investigative Site | Beijing | 100730 | China |
| Novartis Investigative Site | Chengdu | 610083 | China |
| Novartis Investigative Site | Chongqing | 400038 | China |
| Novartis Investigative Site | Guangzhou | 510000 | China |
| Novartis Investigative Site | Guangzhou | 510080 | China |
| Novartis Investigative Site | Guangzhou | 510180 | China |
| Novartis Investigative Site | Nanchang | 330006 | China |
| Novartis Investigative Site | Shanghai | 200092 | China |
| Novartis Investigative Site | Shanghai | 200433 | China |
| Novartis Investigative Site | Tianjin | 300052 | China |
| Novartis Investigative Site | Varaždin | HRV | 42000 | Croatia |
| Novartis Investigative Site | Zagreb | HRV | 10 000 | Croatia |
| Novartis Investigative Site | Petrinja | 44250 | Croatia |
| Novartis Investigative Site | Rijeka | 51000 | Croatia |
| Novartis Investigative Site | Zadar | 23000 | Croatia |
| Novartis Investigative Site | Zagreb | 10000 | Croatia |
| Novartis Investigative Site | Beroun | Czech Republic | 266 01 | Czechia |
| Novartis Investigative Site | Boskovice | Czech Republic | 680 01 | Czechia |
| Novartis Investigative Site | Jablonec nad Nisou | Czech Republic | 466 01 | Czechia |
| Novartis Investigative Site | Jindřichův Hradec | Czech Republic | 377 01 | Czechia |
| Novartis Investigative Site | Kuřim | Czech Republic | 66434 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 14800 | Czechia |
| Novartis Investigative Site | Teplice | Czech Republic | 415 01 | Czechia |
| Novartis Investigative Site | Varnsdorf | Czech Republic | 40747 | Czechia |
| Novartis Investigative Site | Ostrava | CZE | 709 00 | Czechia |
| Novartis Investigative Site | Pilsen | CZE | 301 00 | Czechia |
| Novartis Investigative Site | Teplice | CZE | 415 01 | Czechia |
| Novartis Investigative Site | Břeclav | 690 02 | Czechia |
| Novartis Investigative Site | Český Krumlov | 381 01 | Czechia |
| Novartis Investigative Site | Kutná Hora | 28401 | Czechia |
| Novartis Investigative Site | Nový Bor | 47301 | Czechia |
| Novartis Investigative Site | Pilsen | 323 00 | Czechia |
| Novartis Investigative Site | Prague | 182 00 | Czechia |
| Novartis Investigative Site | Rokycany | 337 22 | Czechia |
| Novartis Investigative Site | Tábor | 390 01 | Czechia |
| Novartis Investigative Site | Alexandria | 21131 | Egypt |
| Novartis Investigative Site | Tallinn | 13619 | Estonia |
| Novartis Investigative Site | Tartu | 51014 | Estonia |
| Novartis Investigative Site | Peine | Lower Saxony | 31224 | Germany |
| Novartis Investigative Site | Koblenz | Rhineland-Palatinate | 56068 | Germany |
| Novartis Investigative Site | Ahlen | 59229 | Germany |
| Novartis Investigative Site | Bamberg | 96049 | Germany |
| Novartis Investigative Site | Berlin | 10119 | Germany |
| Novartis Investigative Site | Berlin | 10247 | Germany |
| Novartis Investigative Site | Berlin | 10367 | Germany |
| Novartis Investigative Site | Berlin | 10717 | Germany |
| Novartis Investigative Site | Berlin | 10787 | Germany |
| Novartis Investigative Site | Berlin | 10969 | Germany |
| Novartis Investigative Site | Berlin | 12157 | Germany |
| Novartis Investigative Site | Berlin | 12159 | Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Berlin | 12627 | Germany |
| Novartis Investigative Site | Berlin | 13057 | Germany |
| Novartis Investigative Site | Berlin | 13086 | Germany |
| Novartis Investigative Site | Berlin | 13156 | Germany |
| Novartis Investigative Site | Berlin | 13187 | Germany |
| Novartis Investigative Site | Bochum | D-44787 | Germany |
| Novartis Investigative Site | Bonn | 53119 | Germany |
| Novartis Investigative Site | Böhlen | 04564 | Germany |
| Novartis Investigative Site | Delitzsch | 04509 | Germany |
| Novartis Investigative Site | Dresden | 01069 | Germany |
| Novartis Investigative Site | Düren | 52349 | Germany |
| Novartis Investigative Site | Düsseldorf | 40211 | Germany |
| Novartis Investigative Site | Erlangen | 91052 | Germany |
| Novartis Investigative Site | Frankfurt | 60313 | Germany |
| Novartis Investigative Site | Frankfurt | 60389 | Germany |
| Novartis Investigative Site | Fürstenwalde | 15517 | Germany |
| Novartis Investigative Site | Halle | 06108 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Hamburg | 22143 | Germany |
| Novartis Investigative Site | Hamburg | 22299 | Germany |
| Novartis Investigative Site | Hamburg | 22335 | Germany |
| Novartis Investigative Site | Hanover | 30173 | Germany |
| Novartis Investigative Site | Hochstadt | 91315 | Germany |
| Novartis Investigative Site | Kassel | 34121 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Leipzig | 04109 | Germany |
| Novartis Investigative Site | Leipzig | 04207 | Germany |
| Novartis Investigative Site | Leipzig | 04275 | Germany |
| Novartis Investigative Site | Ludwigsburg | 71640 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Marburg | D-35037 | Germany |
| Novartis Investigative Site | Mittweida | 09648 | Germany |
| Novartis Investigative Site | München | 81377 | Germany |
| Novartis Investigative Site | Neu-Isenburg | 63263 | Germany |
| Novartis Investigative Site | Neuss | 41462 | Germany |
| Novartis Investigative Site | Potsdam | 14467 | Germany |
| Novartis Investigative Site | Potsdam | 14469 | Germany |
| Novartis Investigative Site | Rheine | 48431 | Germany |
| Novartis Investigative Site | Rüdersdorf | 15562 | Germany |
| Novartis Investigative Site | Schleswig | 24837 | Germany |
| Novartis Investigative Site | Schwedt | 16303 | Germany |
| Novartis Investigative Site | Weinheim | 69469 | Germany |
| Novartis Investigative Site | Witten | 58452 | Germany |
| Novartis Investigative Site | Ciudad | Gautemala | 01010 | Guatemala |
| Novartis Investigative Site | Guatemala City | GTM | 01010 | Guatemala |
| Novartis Investigative Site | Guatemala City | GTM | 01011 | Guatemala |
| Novartis Investigative Site | Guatemala City | 01010 | Guatemala |
| Novartis Investigative Site | Guatemala City | 01011 | Guatemala |
| Novartis Investigative Site | Guatemala City | 01057 | Guatemala |
| Novartis Investigative Site | Budapest | HUN | 1037 | Hungary |
| Novartis Investigative Site | Budapest | HUN | 1089 | Hungary |
| Novartis Investigative Site | Budapest | HUN | 1117 | Hungary |
| Novartis Investigative Site | Budapest | HUN | 1204 | Hungary |
| Novartis Investigative Site | Győr | HUN | 9024 | Hungary |
| Novartis Investigative Site | Hajdúnánás | HUN | 4080 | Hungary |
| Novartis Investigative Site | Makó | HUN | 6900 | Hungary |
| Novartis Investigative Site | Miskolc | HUN | 3529 | Hungary |
| Novartis Investigative Site | Püspökladány | HUN | 4150 | Hungary |
| Novartis Investigative Site | Százhalombatta | HUN | 2440 | Hungary |
| Novartis Investigative Site | Balassagyarmat | 2660 | Hungary |
| Novartis Investigative Site | Budapest | 1106 | Hungary |
| Novartis Investigative Site | Budapest | 1134 | Hungary |
| Novartis Investigative Site | Cegléd | 2700 | Hungary |
| Novartis Investigative Site | Csorna | H-9300 | Hungary |
| Novartis Investigative Site | Dombóvár | 7200 | Hungary |
| Novartis Investigative Site | Gödöllő | 2100 | Hungary |
| Novartis Investigative Site | Hatvan | 3000 | Hungary |
| Novartis Investigative Site | Komárom | 2900 | Hungary |
| Novartis Investigative Site | Miskolc | 3526 | Hungary |
| Novartis Investigative Site | Mosdós | 7257 | Hungary |
| Novartis Investigative Site | Szarvas | 5540 | Hungary |
| Novartis Investigative Site | Szeged | 6720 | Hungary |
| Novartis Investigative Site | Szeged | 6722 | Hungary |
| Novartis Investigative Site | Szigetvár | 7900 | Hungary |
| Novartis Investigative Site | Szombathely | 9700 | Hungary |
| Novartis Investigative Site | Ahmedabad | Gujarat | 380 008 | India |
| Novartis Investigative Site | Ahmedabad | Gujarat | 380016 | India |
| Novartis Investigative Site | Vadodara | Gujarat | 390021 | India |
| Novartis Investigative Site | Mysore | Karnataka | 570001 | India |
| Novartis Investigative Site | Kozhikode | Kerala | 673008 | India |
| Novartis Investigative Site | Mumbai | Maharashtra | 400601 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 440010 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 440012 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 440019 | India |
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| Derived |
| Chapman K, van Zyl-Smit R, Maspero J, Kerstjens HAM, Gon Y, Hosoe M, Tanase AM, Pethe A, Shu X, D'Andrea P. One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. BMJ Open Respir Res. 2021 Aug;8(1):e000819. doi: 10.1136/bmjresp-2020-000819. |
| 32653075 | Derived | van Zyl-Smit RN, Krull M, Gessner C, Gon Y, Noga O, Richard A, de Los Reyes A, Shu X, Pethe A, Tanase AM, D'Andrea P; PALLADIUM trial investigators. Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):987-999. doi: 10.1016/S2213-2600(20)30178-8. Epub 2020 Jul 9. |
| FG002 | MF 800 μg | Mometasone furoate (MF) 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. |
| FG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| FG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized Set (RAN) consisted of all participants who were assigned a randomization number, regardless of whether or not they actually received study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QMF149 150/320 μg | QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening. |
| BG001 | QMF149 150/160 μg | QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening. |
| BG002 | MF 800 μg | MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. |
| BG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| BG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26 | Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | Full Analysis Set (FAS) consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | litre (L) | 26 weeks |
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| Secondary | Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52 | The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit | Posted | Least Squares Mean | Standard Error | score on a scale | Weeks 4, 12, 26 and 52 |
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| Secondary | Trough FEV1 at Week 52 | Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | L | Week 52 |
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| Secondary | Pre-dose FEV1 at Weeks 4 and 12 | Pre-dose trough FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit. | Posted | Least Squares Mean | Standard Deviation | L | Weeks 4 (Day 30) and 12 (Day 86) |
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| Secondary | Post Dose FEV1 (5 Minutes-1 Hour) | Post-dose FEV1 measurements were analyzed at 5 minutes, 15 minutes, 30 minutes and 1 hour. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective time point. | Posted | Least Squares Mean | Standard Error | L | Up to Week 52 (Day 364) |
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| Secondary | Trough Forced Vital Capacity (FVC) | FVC is the total amount of air exhaled during the FEV test. Trough FVC is defined as average of the two FVC measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit. | Posted | Least Squares Mean | Standard Error | L | Up to Week 52 (Day 365) |
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| Secondary | Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75) | FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit. | Posted | Least Squares Mean | Standard Error | Litres/second (L/s) | Up to Week 52 (Day 365) |
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| Secondary | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment | PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose). At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used. | Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study medication. n represents tthe number of participants with data at respective visit. | Posted | Least Squares Mean | Standard Error | L/min | Up to Weeks 26 and 52 |
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| Secondary | Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52 | Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions | FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents number of participants with data at the respective visit. | Posted | Number | percentage of participants | Weeks 26 (Day 183) and 52 (Day 364) |
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| Secondary | Change From Baseline in Percentage of Asthma Symptoms Free Days | All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | percentage of days | Up to Week 52 |
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| Secondary | Change Form Baseline in Percentage of Days With no Daytime Symptoms | All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems). | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | percentage of days | Up to Week 52 |
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| Secondary | Change From Baseline in Percentage of Nights With no Night-time Awakenings | All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems). | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | percentage of nights | Up to Week 52 |
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| Secondary | Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening | All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for mornings with no symptoms on awakening was "Did you have asthma symptoms upon awakening in the morning?" to be answered with "None" with scores from 0 (no problem)-4 (very severe problems). | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | percentage of mornings | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rescue Medication Usage | All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. The number of puffs of rescue medication during the past 12 hours is recorded twice (morning/evening) by the participant prior to taking study medication. The mean daily number of puffs of rescue medication use will be calculated for each participant, done separately for morning (night-time), evening (daytime), and daily (night-time plus daytime) rescue medication use | FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents number of participants included in the analysis. | Posted | Least Squares Mean | Standard Error | number of puffs | Up to Weeks 26 and 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Asthma Exacerbation by Exacerbation Category | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Median | Full Range | days | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Hospitalization for Asthma Exacerbation | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Median | Full Range | days | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annual Rate of Asthma Exacerbations by Exacerbation Category | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Mean | 95% Confidence Interval | exacerbations per year | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration in Days of Asthma Exacerbations by Exacerbation Category | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | FAS consisted of all participant in the RAN set who received at least one dose of study medication. | Posted | Mean | Standard Deviation | days | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | FAS consisted of all patients in the RAN set who received at least one dose of study medication. | Posted | Number | percentage of participants | Up to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations | The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Median | Full Range | days | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Number | percentage of participants | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations | The treatment of asthma exacerbations including the initiation of systemic corticosteroids were done according to investigator's or treating physician's medical judgement and in line with national and international recommendations. If systemic corticosteroids were required, a participant could return to the study after successfully completing a taper of approximately 7-10 days. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Mean | Standard Deviation | milligrams | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percentage of Rescue Medication Free Days | All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. Rescue medication free days is defined as any day where the participant did not use any puffs of rescue medication during daytime and night-time. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents number of participants with data at respective visit. | Posted | Least Squares Mean | Standard Error | percentage of days | Up to Weeks 26 and 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Asthma Quality of Life Questionnaire (AQLQ) | AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). It consists of 4 domains:
| FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | score on a scale | Up to Week 52 (Day 364) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough FEV1 Measured After 26 Weeks of Treatment | Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. | FAS consisted of all participants in the RAN set who received at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | L | Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes | A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee. | Safety Set consisted of all participants who received at least one dose of study medication. | Posted | Number | percentage of participants | Up to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE is any untoward medical occurrence (i.e., any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. An SAE is defined as any adverse event (appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s) or medical conditions(s) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant, i.e. defined as an event that jeopardizes the participants or may require medical or surgical intervention. | Safety Set consisted of all participants who received at least one dose of study medication. | Posted | Number | percentage of participants | Approximately up to 56 weeks |
|
Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QMF 150/320 | QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening. | 0 | 443 | 21 | 443 | 228 | 443 |
| EG001 | QMF 150/160 | QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening. | 0 | 437 | 20 | 437 | 233 | 437 |
| EG002 | MF 800 | MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. | 0 | 440 | 21 | 440 | 263 | 440 |
| EG003 | MF 400 | MF 400 μg was delivered o.d. via Twisthaler® in the evening. | 1 | 443 | 31 | 443 | 290 | 443 |
| EG004 | S/F 50/500 | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. | 0 | 444 | 21 | 444 | 239 | 444 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Corneal deposits | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Accidental device ingestion | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Cerebellar haematoma | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vertebral artery aneurysm | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Calculus urethral | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hydroureter | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cervix enlargement | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Chronic rhinosinusitis with nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2018 | Dec 11, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C510790 | indacaterol |
| D000068656 | Mometasone Furoate |
| C000600413 | QMF149 |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Native American |
|
| Pacific Islander |
|
| Other |
|
| East Asian |
|
| Southeast Asian |
|
| South Asian |
|
| Russian |
|
| Mixed ethnicity |
|
| Not reported |
|
| Unknown |
|
| Other |
|
| <0.001 |
| LS Mean |
| 0.211 |
| Standard Error of the Mean |
| 0.0224 |
| 2-Sided |
| 95 |
| 0.167 |
| 0.255 |
| Superiority |
| OG002 |
| MF 800 μg |
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. |
| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
|
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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| MF 400 μg |
MF 400 μg was delivered o.d via Twisthaler® in the evening |
| OG004 | Salmeterol /Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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MF 400 μg was delivered o.d. via Twisthaler® in the evening.
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
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MF 400 μg was delivered o.d. via Twisthaler® in the evening.
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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|
|
| MF 400 μg |
MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
| OG002 | MF 800 μg | MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. |
| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
|
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
|
| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
|
| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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|
|
| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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|
| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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| OG004 |
| Salmeterol/Fluticasone 50/500 μg |
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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|
| OG004 |
| Salmeterol/Fluticasone 50/500 μg |
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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|
| OG004 |
| Salmeterol/Fluticasone 50/500 μg |
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
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|
| OG004 |
| Salmeterol/Fluticasone 50/500 μg |
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
|
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
| OG004 |
| Salmeterol /Fluticasone 50/500 μg |
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
|
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
| MF 400 μg |
MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
| MF 400 μg |
MF 400 μg was delivered o.d via Twisthaler® in the evening |
| OG004 | Salmeterol /Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
|
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
|
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
|
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
|
|
| OG002 |
| MF 800 μg |
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. |
| OG003 | MF 400 μg | MF 400 μg was delivered o.d. via Twisthaler® in the evening. |
| OG004 | Salmeterol/Fluticasone 50/500 μg | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
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