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Tracking Information | |
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First Received Date † | March 27, 2006 |
Last Updated Date | March 5, 2008 |
Start Date † | April 2006 |
Current Primary Outcome Measures † |
Measure of lung Function |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00308191 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD |
Official Title † | A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease |
Brief Summary | The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone. |
Detailed Description | |
Study Phase | Phase III |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition † | COPD |
Intervention † |
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Study Arms / Comparison Groups | |
Publications * | Tashkin DP, Littner M, Andrews CP, Tomlinson L, Rinehart M, Denis-Mize K. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: A placebo-controlled trial. Respir Med. 2008 Feb 6; [Epub ahead of print] |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 128 |
Completion Date | December 2006 |
Primary Completion Date | May 2006 (final data collection date for primary outcome measure) |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 40 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00308191 |
Responsible Party | Director, Clinical Affairs, Dey L.P. |
Secondary IDs †† | |
Study Sponsor † | Dey |
Collaborators †† | |
Investigators † | |
Information Provided By | Dey |
Verification Date | March 2008 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |