Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
NCT00523991
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:
post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1).
Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years.
Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.
Subjects who have been treated with maintenance medications for chronic respiratory disease
within six months prior to screening.
Subjects with significant diseases other than COPD. Subjects on chronic systemic
corticosteroids.
Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in
the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3
Subjects with a recent (past 6 months) myocardial infarction, any unstable or life
threatening cardiac arrhythmia requiring intervention or change in drug therapy during the
last year; or who have been hospitalized for cardiac failure during the past year.
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Descriptive Information | ||||
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Brief Title ICMJE | Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD). | |||
Official Title ICMJE | A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy | |||
Brief Summary | A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Pulmonary Disease, Chronic Obstructive | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, Weisman IM, Yunis C. Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial. NPJ Prim Care Respir Med. 2014 May 20;24:14003. doi: 10.1038/npjpcrm.2014.3. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 457 | |||
Original Enrollment ICMJE | 436 | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria: All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria: post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1). Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years. Subjects must have a Medical Research Council (MRC) dyspnea score >= 2. Exclusion criteria: Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening. Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids. Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 40 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, Czech Republic, Germany, Greece, Netherlands, Portugal, Ukraine, United Kingdom, United States | |||
Removed Location Countries | Poland | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00523991 | |||
Other Study ID Numbers ICMJE | 205.365 A4471008 ( Other Identifier: OTHER ) 2006-006276-38 ( EudraCT Number: EudraCT ) | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | |||
Study Sponsor ICMJE | Boehringer Ingelheim | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Boehringer Ingelheim | |||
Verification Date | May 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |