Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
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| ClinicalTrials.gov Identifier: NCT01001494 |
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Recruitment Status :
Completed
First Posted : October 26, 2009
Results First Posted : September 17, 2012
Last Update Posted : January 4, 2017
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Chronic Obstructive Pulmonary Disease (COPD) |
| Interventions |
Drug: Aclidinium bromide 200 μg bid Drug: Aclidinium bromide 400 μg bid Drug: Placebo |
| Enrollment | 828 |
Participant Flow
| Recruitment Details | This study was conducted at 103 sites (100/103 randomised patients), 10 sites in the Czech Republic, 5 in France, 17 in Germany, 13 in Hungary, 3 in Italy, 1 in Peru, 21 in Poland, 10 in the Russian Federation, 5 in Spain, 13 in South Africa and 5 in the Ukraine. The first patient was screened in Oct 2009 and the last patient visit was in Nov 2010. |
| Pre-assignment Details | 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. |
| Arm/Group Title | Aclidinium Bromide 200 μg Bid | Aclidinium Bromide 400 μg Bid | Placebo |
|---|---|---|---|
 Arm/Group Description |
Aclidinium bromide 200 μg twice-daily via inhalation | Aclidinium bromide 400 μg twice-daily via inhalation | Placebo via inhalation |
| Period Title: Overall Study | |||
| Started | 277 [1] | 269 [2] | 273 [3] |
| Completed | 253 | 252 | 232 |
| Not Completed | 24 | 17 | 41 |
| Reason Not Completed | |||
| Adverse Event | 8 | 4 | 6 |
| Protocol Violation | 0 | 1 | 1 |
| Lost to Follow-up | 2 | 0 | 1 |
| Withdrawal by Subject | 9 | 7 | 17 |
| COPD exacerbation | 3 | 4 | 5 |
| Lack of Efficacy | 2 | 0 | 8 |
| Other | 0 | 1 | 3 |
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[1]
280 patients were randomized, but baseline data was missing from 3 patients in one center
[2]
272 patients were randomized, but baseline data was missing from 3 patients in one center
[3]
276 patients were randomized, but baseline data was missing from 3 patients in one center
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Baseline Characteristics
| Arm/Group Title | Aclidinium Bromide 200 μg Bid | Aclidinium Bromide 400 μg Bid | Placebo | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Aclidinium bromide 200 μg twice-daily via inhalation | Aclidinium bromide 400 μg twice-daily via inhalation | Placebo via inhalation | Total of all reporting groups | |
| Overall Number of Baseline Participants | 277 | 269 | 273 | 819 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
|||||
| Number Analyzed | 277 participants | 269 participants | 273 participants | 819 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
|
|
| Between 18 and 65 years |
169 61.0%
|
161 59.9%
|
179 65.6%
|
509 62.1%
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|
| >=65 years |
108 39.0%
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108 40.1%
|
94 34.4%
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310 37.9%
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|
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||
| Number Analyzed | 277 participants | 269 participants | 273 participants | 819 participants | |
| 62.3 (7.8) | 62.9 (8.4) | 62.0 (8.0) | 62.4 (8.0) | ||
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Gender
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 277 participants | 269 participants | 273 participants | 819 participants | |
| Female |
96 34.7%
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87 32.3%
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84 30.8%
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267 32.6%
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| Male |
181 65.3%
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182 67.7%
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189 69.2%
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552 67.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 277 participants | 269 participants | 273 participants | 819 participants |
| Spain | 6 | 7 | 5 | 18 | |
| Ukraine | 8 | 8 | 11 | 27 | |
| Russian Federation | 14 | 16 | 15 | 45 | |
| Italy | 4 | 2 | 2 | 8 | |
| France | 8 | 8 | 8 | 24 | |
| Hungary | 35 | 30 | 32 | 97 | |
| Czech Republic | 22 | 20 | 19 | 61 | |
| Poland | 79 | 74 | 77 | 230 | |
| South Africa | 46 | 47 | 48 | 141 | |
| Germany | 55 | 57 | 56 | 168 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
| Name/Title: | AstraZeneca Clinical |
| Organization: | Study Information Center |
| Phone: | 1-877-240-9479 |
| EMail: | information.center@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01001494 |
| Other Study ID Numbers: |
M/34273/34 ATTAIN |
| First Submitted: | October 22, 2009 |
| First Posted: | October 26, 2009 |
| Results First Submitted: | August 14, 2012 |
| Results First Posted: | September 17, 2012 |
| Last Update Posted: | January 4, 2017 |