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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00239421 |
Purpose
This is a six-week, randomized, double-blind, quadruple-dummy parallel group multiple dose study comparing the efficacy and safety of tiotropium inhalation capsules (18 µg per day) plus formoterol inhalation capsules (12 µg twice daily) to salmeterol inhalation aerosol (50 µg b.i.d.) plus fluticasone inhalation aerosol (500 µg b.i.d.) in patients with chronic obstructive pulmonary disease (COPD). Diagnosis and main criteria for inclusion were the following: Outpatients of either sex, aged >= 40 years with a diagnosis of COPD (GOLD criteria); post-bronchodilator FEV1 < 80% predicted [ECSC criteria] and post-bronchodilator FEV1/FVC < 70% at Visit 1, pre-bronchodilator FEV1 <= 65% [ECSC criteria] at Visit 2, smoking history of > 10 pack-years, no history of asthma. Duration of treatment was 42 days.
Criteria for evaluation are the following: FEV1AUC(0-12) and peak FEV1 (obtained within the first three hours of testing) after six weeks, FEV1, FVC, PEFR, rescue medication use, adverse events, pulse rate, blood pressure, physical examination.
Statistical methods: Analysis of covariance with terms for treatment, pooled centre (country) and baseline reading. Descriptive statistics.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Test: Tiotropium 18 µg per day (one inhalation capsule) plus 12 µg formoterol twice daily (two times one inhalation capsule) Drug: Reference: Salmeterol MDI 50 µg (2 puffs of 25 µg each) b.i.d., plus fluticasone propionate MDI 500 µg (2 puffs of 250 µg each) b.i.d. |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Six-Week, Randomized, Double-Blind, Quadruple-Dummy Parallel Group Multiple Dose Study Comparing the Efficacy and Safety of Tiotropium Inhalation Capsules Plus Formoterol Inhalation Capsules to Salmeterol Inhalation Aerosol Plus Fluticasone Inhalation Aerosol in Patients With Chronic Obstructive P |
| Estimated Enrollment: | 492 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | September 2004 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients must have a diagnosis of chronic obstructive pulmonary disease according to the GOLD criteria and must meet the following spirometric criteria:
a post-bronchodilator FEV1 < 80% of predicted normal, a post-bronchodilator FEV1/FVC < 70% at Visit 1, and a morning FEV1 <= 65% predicted at Visit 2.
Exclusion Criteria:
Contacts and Locations
Show 56 Study Locations| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharma GmbH & Co. KG |
More Information
| ClinicalTrials.gov Identifier: | NCT00239421 History of Changes |
| Other Study ID Numbers: | 205.287 |
| Study First Received: | October 14, 2005 |
| Last Updated: | September 29, 2009 |
| Health Authority: | Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM); Austria: Federal Ministry for Health and Women; Belgium: Institutional Review Board; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); South Africa: Medicines Control Council |
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Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Formoterol Salmeterol Fluticasone Tiotropium Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Parasympatholytics |