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The purpose of this study is to evaluate the dose-response of different doses of CHF 781 Pressurized Metered Dose Inhaler (pMDI) on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target patient population.
This is a phase II, multicenter, randomized, double-blind, placebo and active controlled dose ranging 5-arm parallel group study to identify the optimal dose of CHF 781 pMDI with respect to lung function and other clinical efficacy and safety outcomes.
After a 2 week run-in period under rescue albuterol as needed and background inhaled corticosteroid (ICS), patients will be randomized to one of the 5 study treatment groups. After randomization, patients will be assessed after 4 and 8 weeks of study treatment at the center. A follow-up phone call will be performed a week after the last visit.
During the study, daily asthma symptoms, peak expiratory flow, rescue and background medication use, and compliance with the study medication will be recorded via subject diary. Treatment-Emergent Adverse Events (TEAEs) will be assessed and recorded throughout the study. At screening and subsequent visits, patients will undergo physical and vital signs examinations, spirometry measurements, and 12-lead ECG. Routine hematology, blood chemistry, and pregnancy testing will be performed before enrollment and at end of study. 24-hr urine cortisol and creatinine will be assessed before and after the first dose and just before the last dose of study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1; CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID); |
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| Treatment B | Experimental | CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2; CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; |
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| Treatment C | Experimental | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; |
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| Treatment D | Placebo Comparator | Placebo Control, Placebo; CHF 718 pMDI matched Placebo: 4 inhalations BID; |
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| Treatment E | Active Comparator | Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF 718 pMDI | Drug | Dose Response: Test one of three different doses of CHF 718 pMDI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose Morning FEV1 at Week 8 - Change From Baseline | Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second; | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose Morning FEV1 at Week 4 - Change From Baseline | Change from baseline in pre-dose morning FEV1 at Week 4. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Bernstein, MD | Bernstein Clinical Research Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiesi Investigational Site | Birmingham | Alabama | 35244 | United States | ||
| Chiesi Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24107140 | Background | Tilert T, Dillon C, Paulose-Ram R, Hnizdo E, Doney B. Estimating the U.S. prevalence of chronic obstructive pulmonary disease using pre- and post-bronchodilator spirometry: the National Health and Nutrition Examination Survey (NHANES) 2007-2010. Respir Res. 2013 Oct 9;14(1):103. doi: 10.1186/1465-9921-14-103. | |
| 12010839 | Background |
| Label | URL |
|---|---|
| From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A (CHF 718 pMDI 100 µg TDD) | CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1; CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID); TDD of BDP: 100 μg; |
| FG001 | Treatment B (CHF 718 pMDI 400 µg TDD) |
| 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 | Jun 5, 2018 | Oct 29, 2021 |
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| Placebo pMDI | Drug | Placebo Control |
|
| Beclomethasone Dipropionate (BDP) | Drug | Active Control |
|
|
| Baseline, Week 4 |
| Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline | Change from baseline in pre-dose morning FVC at Week 4 and 8. Spirometry, used to measure FVC, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FVC were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FVC=Forced vital capacity; | Baseline, Week 4, Week 8 |
| Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline | The ACQ consists of 7 items: 6 simple self-administered questions referring to asthma control and rescue treatment usage with 1 week recall, and a 7th item consisting of the percent (%) predicted FEV1 completed by clinic staff. Scoring uses a 7-point scale: 0 = "totally controlled" and 6 = "severely uncontrolled". The ACQ score was calculated as the average of all 7 items. Definitions: ACQ-7 score=Asthma Control Questionnaire-7©; Information regarding the American Thoracic Society ACQ questionnaire is also available at: https://member.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php; Baseline ACQ-7 score = ACQ score recorded at V2 (Week 0) Day 1, before randomization; FEV1=Forced expiratory volume in the 1st second; | Baseline, Week 4, Week 8 |
| Average Use of Rescue Medication - Change From Baseline | Change from baseline in average use of rescue medication, during Inter-visit period 1, Inter-visit period 2, Entire treatment period. Definitions: Baseline=For the efficacy variable -- average use of rescue medication -- derived from the electronic diary (eDiary), baseline values were the averages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
| Percentage (%) of Rescue Medication-free Days - Change From Baseline | Change from baseline in percentage (%) of rescue medication-free days. An increased value indicates improvement from baseline. Definitions: Baseline=For the efficacy variable -- percentage (%) of rescue medication-free days -- derived from the electronic diary (eDiary), baseline values were the averages/percentages recorded during the run-in period. Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
| Overall Daily Asthma Symptoms Scores - Change From Baseline | Overall daily asthma symptoms scores - Change From Baseline (am and pm). Subjects had to record asthma symptom score (overall symptoms, cough, wheeze, chest tightness and breathlessness) in the am (night-time asthma symptom score) and in the pm (daytime asthma symptom score). These data were collected in the subject's diary. Daily asthma symptoms score were performed separately for am score and pm score and also as a total, where the total equals the sum of the am and pm scores. Degree of asthma symptoms by score: 0=None, 1=Mild, 2=Moderate, and 3=Severe. Baseline=Averages values during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
| Percentage (%) of Asthma Symptoms-free Days - Change From Baseline | Change from baseline in Percentage (%) of asthma symptoms-free days. Asthma symptoms-free days is the number of days with a total asthma score=0 (daily morning plus evening asthma score). Subjects recorded asthma symptom score as described in the Outcome measure #7. Definitions: Baseline=For the efficacy variables -- daytime and night-time asthma symptom scores -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
| Percentage (%) of Asthma Control Days - Change From Baseline | Change from baseline in percentage (%) of asthma control days, during Inter-visit period 1, Inter-visit period 2, Entire treatment period. This outcome measure was calculated according to the following definition: Days with a total daily morning + evening asthma score = 0 AND No rescue medication use. Definitions: Baseline=For the efficacy variable -- asthma control days -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
| Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline | Change from baseline in pre-dose Peak Expiratory Flow (PEF) (Liters/min), morning and evening measurements. Definitions: Baseline=For the efficacy variable -- morning and evening PEF -- derived from the eDiary, the baseline values were the averages/percentages recorded during the run-in period; PEF=evening peak expiratory flow; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
| Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline | Vital signs (systolic and diastolic blood pressure) at baseline, week 4, and week 8. Change from baseline. Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; DBP=Diastolic blood pressure; SBP=Systolic blood pressure; | Baseline, Week 4, Week 8 |
| 12-lead ECG Parameters - Heart Rate - Change From Baseline | 12-lead electrocardiogram (12-lead ECG) parameter - heart rate (HR) was measured at baseline (Day 1) and Week 8. Change from baseline. Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; bpm=Beats per minute; | Baseline, Week 8 |
| 12-lead ECG Parameters - PR, QRS, QTcF - Change From Baseline. | 12-lead electrocardiogram (12-lead ECG) parameters - PR, QRS, QTcF intervals - were measured at baseline (Day 1) and Week 8. Changes from baseline. Definitions: Baseline=Baseline values were defined at visit 2 (Week 0); QTcF=Fridericia-corrected QT interval; msec=Millisecond; | Baseline, Week 8 |
| 12-lead ECG Parameters - Prolonged QTcF - Change From Baseline | Number of participants with prolonged QTcF. Change from baseline. Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; QTcF=Fridericia-corrected QT interval; | Baseline, Week 8 |
| 24-hr Urine Free Cortisol - Change From Baseline | 24-hr Urinary Free Cortisol - Change From Baseline. For the evaluation of the 24-hr Urine-Free cortisol excretion, 24-hour urine samples were collected. Urine-free cortisol was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; | Baseline, Week 8 |
| 24-hr Creatinine - Change From Baseline. | 24-hr Creatinine - Change From Baseline. For the evaluation of the 24-hr creatinine excretion, 24-hour urine sample were collected. Creatinine was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; | Baseline, Week 8 |
| Montgomery |
| Alabama |
| 36106 |
| United States |
| Chiesi Investigational Site | Phoenix | Arizona | 85014 | United States |
| Chiesi Investigational Site | Surprise | Arizona | 85374 | United States |
| Chiesi Investigational Site | Tempe | Arizona | 85283 | United States |
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| Chiesi Investigational Site | Huntington Beach | California | 92647 | United States |
| Chiesi Investigational Site | Long Beach | California | 90806 | United States |
| Chiesi Investigational Site | Los Angeles | California | 90017 | United States |
| Chiesi Investigational Site | Los Angeles | California | 90025 | United States |
| Chiesi Investigational Site | Los Angeles | California | 90048 | United States |
| Chiesi Investigational Site | Newport Beach | California | 92663 | United States |
| Chiesi Investigational Site | North Hollywood | California | 91606 | United States |
| Chiesi Investigational Site | Rolling Hills Estates | California | 90274 | United States |
| Chiesi Investigational Site | Sacramento | California | 95821 | United States |
| Chiesi Investigational Site | San Diego | California | 92120 | United States |
| Chiesi Investigational Site | San Diego | California | 92123 | United States |
| Chiesi Investigational Site | San Jose | California | 95117 | United States |
| Chiesi Investigational Site | Tustin | California | 92780 | United States |
| Chiesi Investigational Site | Westminster | California | 92683 | United States |
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| Chiesi Investigational Site | Greenfield | Wisconsin | 53228 | United States |
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CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; TDD of BDP: 400 μg;
| FG002 | Treatment C (CHF 718 pMDI 800 µg TDD) | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; TDD of BDP: 800 μg; |
| FG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| FG004 | Treatment E (QVAR^® 320 µg TDD) | Beclomethasone dipropionate Hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate Hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
| COMPLETED |
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| NOT COMPLETED |
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Demographic characteristics are presented for the Intention-to-treat (ITT) study population; this explains the differences in the randomized patient numbers that are shown in the Participant Flow.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A | CHF 718 pMDI 100 µg TDD |
| BG001 | Treatment B | CHF 718 pMDI 400 µg TDD |
| BG002 | Treatment C | CHF 718 pMDI 800 µg TDD |
| BG003 | Treatment D | Placebo Control |
| BG004 | Treatment E | Beclomethasone dipropionate Hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate Hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID, Total Daily Dose (TDD) of BDP: 320 μg; |
| 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, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
| ||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| ||||||||||
| Time since first diagnosis of asthma | Median | Full Range | months |
| ||||||||||
| Age at first diagnosis of asthma | Mean | Standard Deviation | years |
| ||||||||||
| Asthma medication category at study entry | Count of Participants | Participants |
| |||||||||||
| ICS dose before study | Count of Participants | Participants |
| |||||||||||
| Smoking habits | Count of Participants | Participants |
| |||||||||||
| Duration of smoking | Explain why number analyzed in row differs from overall. This was a trial with asthma patients. Only prior smokers were anlayzed for duration of smoking. | Mean | Standard Deviation | years |
| |||||||||
| Number of pack-years | Measure Description: A pack-year is a term used to describe the approximate number of cigarettes a person has smoked over time. 1 One pack-year equals 20 manufactured cigarettes smoked per day for one year. | Explain why number analyzed in row differs from overall. This was a trial of asthma patients. Pack years are only reported for ex-smokers. For one patients in Arm D, the number of pack years was not reported. | Median | Full Range | pack-years |
| ||||||||
| FEV1 at baseline | Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath during the first second (FEV1). | Mean | Standard Deviation | litres |
| |||||||||
| FEV1 (% predicted normal value) at baseline | Mean | Standard Deviation | percent of predicted normal value |
| ||||||||||
| FVC at baseline | Forced vital capacity (FVC) is the maximal volume of gas that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible. | Mean | Standard Deviation | litres |
| |||||||||
| FEV1/FVC at baseline | Mean | Standard Deviation | ratio of the parameters |
|
| 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 | Pre-dose Morning FEV1 at Week 8 - Change From Baseline | Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second; | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Week 8 |
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| Secondary | Pre-dose Morning FEV1 at Week 4 - Change From Baseline | Change from baseline in pre-dose morning FEV1 at Week 4. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second; | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Week 4 |
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| Secondary | Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline | Change from baseline in pre-dose morning FVC at Week 4 and 8. Spirometry, used to measure FVC, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FVC were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FVC=Forced vital capacity; | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Week 4, Week 8 |
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| Secondary | Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline | The ACQ consists of 7 items: 6 simple self-administered questions referring to asthma control and rescue treatment usage with 1 week recall, and a 7th item consisting of the percent (%) predicted FEV1 completed by clinic staff. Scoring uses a 7-point scale: 0 = "totally controlled" and 6 = "severely uncontrolled". The ACQ score was calculated as the average of all 7 items. Definitions: ACQ-7 score=Asthma Control Questionnaire-7©; Information regarding the American Thoracic Society ACQ questionnaire is also available at: https://member.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php; Baseline ACQ-7 score = ACQ score recorded at V2 (Week 0) Day 1, before randomization; FEV1=Forced expiratory volume in the 1st second; | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 4, Week 8 |
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| Secondary | Average Use of Rescue Medication - Change From Baseline | Change from baseline in average use of rescue medication, during Inter-visit period 1, Inter-visit period 2, Entire treatment period. Definitions: Baseline=For the efficacy variable -- average use of rescue medication -- derived from the electronic diary (eDiary), baseline values were the averages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | puffs/day | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
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| Secondary | Percentage (%) of Rescue Medication-free Days - Change From Baseline | Change from baseline in percentage (%) of rescue medication-free days. An increased value indicates improvement from baseline. Definitions: Baseline=For the efficacy variable -- percentage (%) of rescue medication-free days -- derived from the electronic diary (eDiary), baseline values were the averages/percentages recorded during the run-in period. Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | % of rescue medication-free days | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
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| Secondary | Overall Daily Asthma Symptoms Scores - Change From Baseline | Overall daily asthma symptoms scores - Change From Baseline (am and pm). Subjects had to record asthma symptom score (overall symptoms, cough, wheeze, chest tightness and breathlessness) in the am (night-time asthma symptom score) and in the pm (daytime asthma symptom score). These data were collected in the subject's diary. Daily asthma symptoms score were performed separately for am score and pm score and also as a total, where the total equals the sum of the am and pm scores. Degree of asthma symptoms by score: 0=None, 1=Mild, 2=Moderate, and 3=Severe. Baseline=Averages values during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
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| Secondary | Percentage (%) of Asthma Symptoms-free Days - Change From Baseline | Change from baseline in Percentage (%) of asthma symptoms-free days. Asthma symptoms-free days is the number of days with a total asthma score=0 (daily morning plus evening asthma score). Subjects recorded asthma symptom score as described in the Outcome measure #7. Definitions: Baseline=For the efficacy variables -- daytime and night-time asthma symptom scores -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | % of of asthma symptom-free days | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
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| Secondary | Percentage (%) of Asthma Control Days - Change From Baseline | Change from baseline in percentage (%) of asthma control days, during Inter-visit period 1, Inter-visit period 2, Entire treatment period. This outcome measure was calculated according to the following definition: Days with a total daily morning + evening asthma score = 0 AND No rescue medication use. Definitions: Baseline=For the efficacy variable -- asthma control days -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | % of asthma control days | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
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| Secondary | Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline | Change from baseline in pre-dose Peak Expiratory Flow (PEF) (Liters/min), morning and evening measurements. Definitions: Baseline=For the efficacy variable -- morning and evening PEF -- derived from the eDiary, the baseline values were the averages/percentages recorded during the run-in period; PEF=evening peak expiratory flow; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening | Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline. | Posted | Least Squares Mean | 95% Confidence Interval | Liters/min | Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks) |
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| Secondary | Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline | Vital signs (systolic and diastolic blood pressure) at baseline, week 4, and week 8. Change from baseline. Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; DBP=Diastolic blood pressure; SBP=Systolic blood pressure; | Safety population: All randomized patients who received at least one dose of study treatment. | Posted | Mean | Full Range | mmHg | Baseline, Week 4, Week 8 |
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| Secondary | 12-lead ECG Parameters - Heart Rate - Change From Baseline | 12-lead electrocardiogram (12-lead ECG) parameter - heart rate (HR) was measured at baseline (Day 1) and Week 8. Change from baseline. Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; bpm=Beats per minute; | Safety population: All randomized patients who received at least one dose of study treatment. | Posted | Mean | Full Range | bpm | Baseline, Week 8 |
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| Secondary | 12-lead ECG Parameters - PR, QRS, QTcF - Change From Baseline. | 12-lead electrocardiogram (12-lead ECG) parameters - PR, QRS, QTcF intervals - were measured at baseline (Day 1) and Week 8. Changes from baseline. Definitions: Baseline=Baseline values were defined at visit 2 (Week 0); QTcF=Fridericia-corrected QT interval; msec=Millisecond; | Safety population: All randomized patients who received at least one dose of study treatment. | Posted | Mean | Full Range | msec | Baseline, Week 8 |
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| Secondary | 12-lead ECG Parameters - Prolonged QTcF - Change From Baseline | Number of participants with prolonged QTcF. Change from baseline. Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; QTcF=Fridericia-corrected QT interval; | Safety population: All randomized patients who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline, Week 8 |
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| Secondary | 24-hr Urine Free Cortisol - Change From Baseline | 24-hr Urinary Free Cortisol - Change From Baseline. For the evaluation of the 24-hr Urine-Free cortisol excretion, 24-hour urine samples were collected. Urine-free cortisol was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; | Safety population: All randomized patients who received at least one dose of study treatment. | Posted | Median | Full Range | nmol/day | Baseline, Week 8 |
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| Secondary | 24-hr Creatinine - Change From Baseline. | 24-hr Creatinine - Change From Baseline. For the evaluation of the 24-hr creatinine excretion, 24-hour urine sample were collected. Creatinine was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; | Safety population: All randomized patients who received at least one dose of study treatment. | Posted | Median | Full Range | umol/mol | Baseline, Week 8 |
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From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment.
The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
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 | Treatment A (CHF 718 pMDI 100 µg TDD) | CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1; CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID); | 0 | 119 | 1 | 119 | 18 | 119 |
| EG001 | Treatment B (CHF 718 pMDI 400 µg TDD) | CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2; CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; | 1 | 120 | 2 | 120 | 8 | 120 |
| EG002 | Treatment C (CHF 718 pMDI 800 µg TDD) | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; | 0 | 121 | 2 | 121 | 25 | 121 |
| EG003 | Treatment D (Placebo) | Placebo Control, Placebo; CHF 718 pMDI matched Placebo: 4 inhalations BID; | 0 | 124 | 1 | 124 | 28 | 124 |
| EG004 | Treatment E (QVAR^®, 320 µg TDD) | QVAR^®, : Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID; | 0 | 124 | 0 | 124 | 21 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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Chiesi can publish and/or present any results of this study at scientific meetings, and to submit the clinical trial data to national and international Regulatory Authorities. Chiesi reserves the right to use such data for industrial purposes. Investigators will inform Chiesi before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation. Data from individual study sites must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Transparency | Chiesi Farmaceutici S.p.A. | + 39 0521 2791 | clinicaltrials_info@chiesi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2019 | Oct 29, 2021 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
Not provided
Not provided
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| Leukotriene Receptor Antagonist (LTRA) |
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| Theophylline |
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| Inhaled Corticosteroid (ICS) alone |
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| ICS/ Long-Acting β2-agonist (LABA), (free or fixed combination) |
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| ICS/Long-Acting Muscarinic Antagonist (LAMA), (free combination) |
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| ICS/LABA/LAMA |
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| Short-Acting Muscarinic Antagonist (SAMA) |
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| SAMA/SABA |
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| Medium daily dose |
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| Non-smoker |
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| Mixed Models Analysis |
| 0.015 |
| Mean Difference (Final Values) |
| 0.113 |
| 2-Sided |
| 95 |
| 0.018 |
| 0.209 |
| Superiority |
| Comparison treatment groups were: Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo) | Mixed Models Analysis | 0.059 | Mean Difference (Final Values) | 0.093 | 2-Sided | 95 | -0.003 | 0.188 | Superiority |
| Comparison treatment groups were: Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD) | Mixed Models Analysis | 0.090 | Mean Difference (Final Values) | 0.069 | 2-Sided | 95 | -0.011 | 0.150 | Superiority |
| Comparison treatment groups were: Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD) | Mixed Models Analysis | 0.231 | Mean Difference (Final Values) | 0.049 | 2-Sided | 95 | -0.031 | 0.129 | Superiority |
| Comparison treatment groups were: Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD) | Mixed Models Analysis | 0.612 | Mean Difference (Final Values) | -0.021 | 2-Sided | 95 | -0.101 | 0.059 | Superiority |
| Comparison treatment groups were: Treatment E (QVAR^®, 320 µg TDD) vs Treatment D (Placebo) | Mixed Models Analysis | 0.011 | Mean Difference (Final Values) | 0.102 | 2-Sided | 95 | 0.023 | 0.180 | Superiority |
| OG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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| OG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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| OG002 | Treatment C (CHF 718 pMDI 800 µg TDD) | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; |
| OG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
| OG002 | Treatment C (CHF 718 pMDI 800 µg TDD) | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; |
| OG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2; CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; |
| OG002 | Treatment C (CHF 718 pMDI 800 µg TDD) | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; |
| OG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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| OG001 | Treatment B (CHF 718 pMDI 400 µg TDD) | CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2; CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; |
| OG002 | Treatment C (CHF 718 pMDI 800 µg TDD) | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; |
| OG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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| OG001 |
| Treatment B (CHF 718 pMDI 400 µg TDD) |
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2; CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; |
| OG002 | Treatment C (CHF 718 pMDI 800 µg TDD) | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; |
| OG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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| Treatment B (CHF 718 pMDI 400 µg TDD) |
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2; CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; |
| OG002 | Treatment C (CHF 718 pMDI 800 µg TDD) | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; |
| OG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2; CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; |
| OG002 | Treatment C (CHF 718 pMDI 800 µg TDD) | CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; |
| OG003 | Treatment D (Placebo) | Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID);
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID); |
| OG004 | Treatment E (QVAR^®, 320 µg TDD) | Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID; |
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