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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00662792 |
The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung function response over the comparator treatments inhaled in their established dose regimens when administered for 6-week periods to patients with chronic obstructive pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.
Condition | Intervention | Phase |
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Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium plus Salmeterol Drug: Tiotropium Drug: Salmeterol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind Clinical Efficacy and Safety Comparison of Tiotropium/Salmeterol 7.5/25 Mcg Inhalation Powder in the Morning Via Tiotropium/Salmeterol HandiHaler, Tiotropium 18 Mcg Inhalation Powder in the Morning Via Spiriva HandiHaler, Salmeterol 50 Mcg MDPI in the Morning and Evening and the Free Combination Tiotropium 18 Mcg Inhalation Powder in the Morning Via Spiriva HandiHaler Plus Salmeterol 50 Mcg MDPI in the Morning and Evening Following Chronic Administration (6-Week Treatment Periods) in Patients With COPD |
Estimated Enrollment: | 140 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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 COPD and must meet the following criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Germany | |
1184.13.1301 Boehringer Ingelheim Investigational Site | Completed |
Mannheim, Germany | |
1184.13.1305 Boehringer Ingelheim Investigational Site | Recruiting |
Mainz, Germany | |
1184.13.1306 Boehringer Ingelheim Investigational Site | Recruiting |
Rodgau-Dudenhofen, Germany | |
1184.13.1307 Boehringer Ingelheim Investigational Site | Recruiting |
Schwerin, Germany | |
1184.13.1308 Boehringer Ingelheim Investigational Site | Active, not recruiting |
Cottbus, Germany | |
1184.13.1302 Boehringer Ingelheim Investigational Site | Recruiting |
Berlin, Germany | |
1184.13.1304 Boehringer Ingelheim Investigational Site | Recruiting |
Wiesbaden, Germany | |
1184.13.1310 Boehringer Ingelheim Investigational Site | Active, not recruiting |
Rüdersdorf, Germany | |
1184.13.1311 Boehringer Ingelheim Investigational Site | Active, not recruiting |
Großhansdorf, Germany | |
1184.13.1312 Boehringer Ingelheim Investigational Site | Active, not recruiting |
Hamburg, Germany | |
1184.13.1303 Boehringer Ingelheim Investigational Site | Recruiting |
Wiesloch, Germany | |
1184.13.1309 Boehringer Ingelheim Investigational Site | Recruiting |
Berlin, Germany |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1184.13, n.a. |
Study First Received: | April 17, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00662792 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |
Neurotransmitter Agents Salmeterol Cholinergic Antagonists Adrenergic Agents Adrenergic beta-Agonists Anti-Asthmatic Agents Cholinergic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Chronic Disease Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Parasympatholytics Neurotransmitter Agents Disease Attributes Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Cholinergic Agents Adrenergic Agonists Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases |
Therapeutic Uses Tiotropium Salmeterol Adrenergic beta-Agonists Anti-Asthmatic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Chronic Disease Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |