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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 1, 2010 |
| Last Updated Date | November 5, 2010 |
| Start Date ICMJE | February 2010 |
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
FEV1 AUC 0-12h [ Time Frame: Day 14 ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01078623 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
morning pre-dose FEV1 and morning peak FEV1 [ Time Frame: Day 14 ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate |
| Official Title ICMJE | Efficacy, Safety and Tolerability of Two Fixed-Dose Combinations of Aclidinium Bromide With Two Doses of Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo All Administered Twice Daily in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease Patients. |
| Brief Summary | The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD. Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose. |
| Detailed Description | |
| Study Type ICMJE | Interventional |
| Study Phase | Phase II |
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Condition ICMJE | Chronic Obstructive Pulmonary Disease |
| Intervention ICMJE |
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| Study Arms |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 120 |
| Completion Date | |
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 40 Years to 80 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Czech Republic, Germany, Hungary, Poland, Romania |
| Administrative Information | |
| NCT Number ICMJE | NCT01078623 |
| Other Study ID Numbers ICMJE | M/40464/26 |
| Has Data Monitoring Committee | No |
| Responsible Party | Estrella Garcia, Almirall |
| Study Sponsor ICMJE | Almirall, S.A. |
| Collaborators ICMJE | Forest Laboratories |
| Investigators ICMJE | |
| Information Provided By | Almirall, S.A. |
| Verification Date | November 2010 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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