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| ID | Type | Description | Link |
|---|---|---|---|
| LAS29 |
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The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aclidinium bromide 100 μg bid | Experimental | Aclidininum bromide 100 μg twice daily by inhalation |
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| Aclidininum bromide 200 μg bid | Experimental | Aclidininum bromide 200 μg twice daily by inhalation |
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| Aclidininum bromide 400 μg bid | Experimental | Aclidininum bromide 400 μg twice daily by inhalation |
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| Placebo | Placebo Comparator | Placebo twice-daily by inhalation |
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| Formoterol 12 μg bid | Active Comparator | Formoterol 12 μg twice daily by inhalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium bromide 100 μg bid | Drug | Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment | Day 7 | |
| Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Garcia, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Investigational Sites#1 | Ghent | B-9000 | Belgium | |||
| Almirall Investigational Sites#3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22497752 | Derived | Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther. 2012 Jun;25(3):248-53. doi: 10.1016/j.pupt.2012.03.008. Epub 2012 Apr 4. |
| Label | URL |
|---|---|
| Almirall Corporate Website | 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 ± 3 days to assess patient's disease stability.
This study was conducted at a total of 11 centres; 10 in Germany and 1 in Belgium. The first patient was screened in Apr 2010 and the last patient visit was in Aug 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol | The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days. In period 1, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 2, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 3, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 4, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 5, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Aclidinium bromide 200 μg bid | Drug | Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
|
| Aclidininum bromide 400 μg bid | Drug | Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
|
| Placebo | Drug | Placebo via inhalation in the morning and evening for 7 days |
|
| Formoterol 12 μg bid | Drug | Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days |
|
| Day 7 |
| Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment | Day 7 |
| Berlin |
| 10117 |
| Germany |
| Almirall Investigational Sites#4 | Berlin | 13125 | Germany |
| Almirall Investigational Sites#9 | Berlin | 14050 | Germany |
| Almirall Investigational Sites#8 | Frankfurt | 60596 | Germany |
| Almirall Investigational Sites#1 | Groβhansdorf | 22927 | Germany |
| Almirall Investigational Sites#5 | Hamburg | 20249 | Germany |
| Almirall Investigational Sites#7 | Hanover | 30159 | Germany |
| Almirall Investigational Sites#2 | Hanover | 30625 | Germany |
| Almirall Investigational Sites#6 | Schwerin | 19055 | Germany |
| Almirall Investigational Sites#10 | Wiesbaden | 65187 | Germany |
| CSR Synopsis | View source |
| FG001 | Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo | The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days. In period 1, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 2, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 3, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 4, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days. In period 5, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. |
| FG002 | Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100 | The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days. In period 1, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 2, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days. In period 3, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 4, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 5, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. |
| FG003 | Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200 | The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days. In period 1, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days. In period 2, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 3, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 4, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 5, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. |
| FG004 | Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400 | The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days. In period 1, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 2, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 3, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days. In period 4, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. In period 5, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days. |
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| NOT COMPLETED |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| Treatment Period 4 |
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| Treatment Period 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All patients randomized into the crossover study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 7 |
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| Secondary | Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 7 |
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| Secondary | Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 7 |
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| Secondary | Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 7 |
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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 100 μg Bid | Aclidinium bromide 100 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days. | 0 | 73 | 4 | 73 | ||
| EG001 | Aclidinium Bromide 200 μg Bid | Aclidinium bromide 200 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days. | 1 | 73 | 4 | 73 | ||
| EG002 | Aclidinium Bromide 400 μg Bid | Aclidinium bromide 400 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days. | 1 | 74 | 5 | 74 | ||
| EG003 | Formoterol 12 μg Bid | Formoterol 12 μg twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days. | 0 | 74 | 2 | 74 | ||
| EG004 | Placebo | Inhaled placebo dose for 7 days. | 2 | 76 | 1 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Infectious exacerbation of chronic obstructive pulmonary disease | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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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 |
| C494814 | BID protein, human |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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| Withdrawal by Subject |
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| Adverse Event |
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| Withdrawal by Subject |
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Placebo via inhalation
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Placebo via inhalation
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Placebo via inhalation
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