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The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aclidinium bromide | Experimental | Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment |
|
| Tiotropium | Active Comparator | Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment |
|
| Placebo | Placebo Comparator | Placebo comparator administered during 6 weeks of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium bromide | Drug | Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment | Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment | Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval. | Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Garcia, Ph.D. | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Investigational Site #9 | Humpolec | 396 26 | Czechia | |||
| Almirall Investigational Site #1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28074135 | Derived | McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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Patients fulfilling inclusion/exclusion criteria at the time of the screening visit were entered into a run-in period of 14-21 days to assess disease stability.
This study was conducted in 49 sites investigators in 4 countries (3 sites in the Czech Republic, 23 in Germany, 8 in Hungary and 15 in Poland). 8 sites (3 in Germany, 3 in Hungary and 2 in Poland) did not randomise any patients. The first patient was screened in Oct 2011 and the last patient visit was in Mar 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aclidinium Bromide 400 µg BID | Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tiotropium | Drug | Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) |
|
| Placebo | Drug | Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h). |
|
| Jaroměř |
| 551 01 |
| Czechia |
| Almirall Investigational Site #3 | Mělník | 276 01 | Czechia |
| Almirall Investigational Site #4 | Berlin | 10117 | Germany |
| Almirall Investigational Site #12 | Berlin | 10717 | Germany |
| Almirall Investigational Site #10 | Berlin | 10969 | Germany |
| Almirall Investigational Site #8 | Berlin | 13125 | Germany |
| Almirall Investigational Site #20 | Berlin | 13507 | Germany |
| Almirall Investigational Site #21 | Berlin | 14050 | Germany |
| Almirall Investigational Site #2 | Berlin | 14057 | Germany |
| Almirall Investigational Site #24 | Cologne | 51069 | Germany |
| Almirall Investigational Site #13 | Dresden | Germany |
| Almirall Investigational Site #9 | Frankfurt | 60596 | Germany |
| Almirall Investigational Site #3 | Großhansdorf | 22927 | Germany |
| Almirall Investigational Site #1 | Hamburg | 20253 | Germany |
| Almirall Investigational Site #18 | Hamburg | 22143 | Germany |
| Almirall Investigational Site #5 | Hanover | 30159 | Germany |
| Almirall Investigational Site #22 | Hanover | 30625 | Germany |
| Almirall Investigational Site #14 | Jena | 07740 | Germany |
| Almirall Investigational Site #17 | Lübeck | 23552 | Germany |
| Almirall Investigational Site #23 | Rüdersdorf | 15562 | Germany |
| Almirall Investigational Site #6 | Schwerin | 19055 | Germany |
| Almirall Investigational Site #16 | Wiesbaden | 65187 | Germany |
| Almirall Investigational Site #4 | Debrecen | 4043 | Hungary |
| Almirall Investigational Site #2 | Komárom | 2900 | Hungary |
| Almirall Investigational Site #3 | Mátraháza | 3233 | Hungary |
| Almirall Investigational Site #1 | Szarvas | 5540 | Hungary |
| Almirall Investigational Site #11 | Szigetszentmiklós | 2310 | Hungary |
| Almirall Investigational Site #18 | Bialystok | 15-540 | Poland |
| Almirall Investigational Site #8 | Bialystok | 15-540 | Poland |
| Almirall Investigational Site #2 | Elblag | 82-300 | Poland |
| Almirall Investigational Site #17 | Krakow | 31-023 | Poland |
| Almirall Investigational Site #10 | Krakow | 31-455 | Poland |
| Almirall Investigational Site #16 | Lodz | 90-153 | Poland |
| Almirall Investigational Site #20 | Lodz | 90-153 | Poland |
| Almirall Investigational Site #4 | Proszowice | 32-100 | Poland |
| Almirall Investigational Site #6 | Sopot | 84-741 | Poland |
| Almirall Investigational Site #14 | Tarnów | 33-100 | Poland |
| Almirall Investigational Site #19 | Warsaw | 01-138 | Poland |
| Almirall Investigational Site #12 | Wilkowice-Bystra | 43-365 | Poland |
| Almirall Investigational Site #13 | Wroclaw | 50-349 | Poland |
| FG001 | Tiotropium 18 μg Once-daily | Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler. |
| FG002 | Placebo | Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aclidinium Bromide 400 µg BID | Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler. |
| BG001 | Tiotropium 18 μg Once-daily | Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler. |
| BG002 | Placebo | Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h). |
| BG003 | 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 |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment | Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval. | Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value | Posted | Least Squares Mean | Standard Error | Liters | Week 6 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment | Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval. | Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value | Posted | Least Squares Mean | Standard Error | Liters | Week 6 |
|
8 Weeks
A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aclidinium Bromide 400 µg BID | Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler. | 3 | 171 | 16 | 171 | ||
| EG001 | Tiotropium 18 μg Once-daily | Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler. | 4 | 158 | 17 | 158 | ||
| EG002 | Placebo | Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h). | 0 | 85 | 6 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mental Disorder | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment | Per protocol, only COPD exacerbations (worsening of COPD symptoms for at least 2 consecutive days that required a change in the patient's COPD treatment) were reported as AEs |
|
| Peripheral Vascular Disorder | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
All the information related to this clinical trial is considered strictly confidential and is the property of Almirall. This information will not be given to a third party without the written consent of Almirall. Publication and/or presentation, whether complete or partial, of any part of the data or results of this trial will be subject to revision and written agreement between the investigator and Almirall.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical | Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C542859 | aclidinium bromide |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| Male |
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| Czech Republic |
|
| Poland |
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| Germany |
|
| OG002 | Placebo | Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h). |
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