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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00563381 |
This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who withdraw prematurely from trial medication will be encouraged to remain in the trial and participate in follow-up telephone contacts until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of randomised treatment). The phone calls will be made at all scheduled visits.
The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD exacerbations.
The primary endpoint is time to first COPD exacerbation during the 52 week randomised treatment period. A COPD exacerbation will be defined as a complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation.
The onset of an exacerbation is defined as the onset of the first new or increased reported symptom. The end of the exacerbation should be recorded as defined by the investigator.
Only COPD exacerbations with onset during randomised treatment will be included in the analysis.
Condition | Intervention | Phase |
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Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium bromide Drug: Salmeterol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-Blind, Double-Dummy, Parallel Group, One-Year Study). |
Estimated Enrollment: | 6800 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | March 2010 (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 chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1:
Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 <=70% of predicted normal and FEV1 <=70% of FVC post-bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC.
For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) - 2.49 Females:FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) - 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) - 0.029 x age (years) - 2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres)) - 0.025 x age (years) - 2.60
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 205.389, EUDRACT2007-001840-33 |
Study First Received: | November 22, 2007 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00563381 |
Health Authority: | Austria: AGES, Oesterreichische Agentur für Gesundheit und Ernaehrungssicherheit; Belgium: AFMPS - Agence Fédérale des Médicaments et des Produits des Santé; Bulgaria: Bulgarian Drug Agency; Czech Republic: State Institute for Drug Control; Denmark: The Danish Medicines Agency; Finland: National Agency for Medicines; France: AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé); Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte); Great Britain: Medicines and Heathcare Products Regulatory Agency; Greece: Ministry of Health (EOF); Hungary: ORSZÁGOS GYÓGYSZERÉSZETI INTÉZET; Israel: not applicable; Italy: COMITATO ETICO DELLA PROVINCIA DI FERRARA; Latvia: State Agency of Medicines; Lithuania: Lithuanian Bioethics Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency; Poland: Agency for Registration of Medicinal Products, Medical Devices & Biocides; Portugal: INFARMED - Instituto Nacional da Farmácia e do Medicamento; Romania: National Medicines Agency; Russia: Federal Service On Surveillance In Healthcare And Social Development Of Russian Federation; Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Turkey: Ministery Of Health / Central Ethics Committee; Ukraine: The State Pharmacological Center of Ministry of Health of Ukraine; United States: Food and Drug Administration |
Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Bromides |
Lung Diseases Chronic Disease Tiotropium Pulmonary Disease, Chronic Obstructive |
Parasympatholytics Respiratory System Agents Disease Attributes Neurotransmitter Agents Cholinergic Antagonists Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Cholinergic Agents Adrenergic Agonists Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |