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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: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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
Hide Study Locations| Austria | |
| Boehringer Ingelheim Investigational Site | |
| Wien, Austria, 1120 | |
| Med. Uni.-Klinik Graz | |
| Graz, Austria, 8036 | |
| Klinikum Kreuzschwestern Wels | |
| Wels, Austria, 4600 | |
| Belgium | |
| Heilig Hartziekenhuis Campus Menen | |
| Menen, Belgium, 8930 | |
| Sint-Vincentius Ziekenhuis | |
| Antwerpen, Belgium, 2018 | |
| CHU Notre Dame des Bruyères | |
| Chênée, Belgium, 4032 | |
| Boehringer Ingelheim Investigational Site | |
| Vosselaar, Belgium, 2350 | |
| Denmark | |
| Hvidovre Hospital | |
| Hvidovre, Denmark, DK-2650 | |
| Bispebjerg Hospital | |
| Copenhagen NV, Denmark, DK-2400 | |
| Lungemedicinsk Forskning 2B | |
| Aarhus, Denmark, DK-8000 | |
| Amtssygehuset i Gentofte | |
| Hellerup, Denmark, DK-2900 | |
| Odense Universitetshospital | |
| Odense C, Denmark, DK-5000 | |
| France | |
| Boehringer Ingelheim Investigational Site | |
| Grenoble, France, 38100 | |
| Centre Hospitalier Germon et Gauthier | |
| Beuvry, France, 62660 | |
| Clinique de la Louvière | |
| Lille Cedex, France, 59042 | |
| Hôpital Gabriel Montpied | |
| Clermont Ferrand cedex 1, France, 63003 | |
| Boehringer Ingelheim Investigational Site | |
| Lagord, France, 17140 | |
| Germany | |
| MEDARS GmbH | |
| Berlin, Germany, 14057 | |
| Boehringer Ingelheim Investigational Site | |
| Kiel, Germany, 24105 | |
| Otto-von-Guericke-Universtität Magdeburg | |
| Magdeburg, Germany, 39120 | |
| am Krankenhaus Großhansdorf | |
| Großhansdorf, Germany, 22927 | |
| Boehringer Ingelheim Investigational Site | |
| Hannover, Germany, 30176 | |
| ClinPharm International GmbH & Co. KG | |
| Leipzig, Germany, 04229 | |
| Boehringer Ingelheim Investigational Site | |
| Gelnhausen, Germany, 63571 | |
| Klinikum der Ruhr-Universität Bochum | |
| Bochum, Germany, 44791 | |
| Boehringer Ingelheim Investigational Site | |
| Minden, Germany, 32423 | |
| Klinikum der Universität zu Köln | |
| Köln, Germany, 50931 | |
| Pneumologisches Forschungsinstitut GmbH | |
| Hamburg, Germany, 20535 | |
| Boehringer Ingelheim Investigational Site | |
| München, Germany, 80634 | |
| Boehringer Ingelheim Investigational Site | |
| Berlin, Germany, 13597 | |
| Boehringer Ingelheim Investigational Site | |
| Frankfurt/Main, Germany, 60323 | |
| ClinGuard GmbH | |
| Dortmund, Germany, 44263 | |
| Inamed Research GmbH & Co. KG | |
| Gauting, Germany, 82131 | |
| Netherlands | |
| lokatie Langendijk | |
| Breda, Netherlands, 4819 EV | |
| UMC St Radboud ziekenhuis | |
| Nijmegen, Netherlands, 6525 GA | |
| Catharina Hospital | |
| Eindhoven, Netherlands, 5623 EJ | |
| Polikliniek Longziekten | |
| Heerlen, Netherlands, 6419 PC | |
| Sint Franciscus Gasthuis | |
| Rotterdam, Netherlands, 3045 PM | |
| Poli Longziekten | |
| Almelo, Netherlands, 7609 PP | |
| Poli Longziekten | |
| Hengelo, Netherlands, 7555 DL | |
| Afdeling CardioSearch | |
| Veldhoven, Netherlands, 5504 DB | |
| South Africa | |
| Boehringer Ingelheim Investigational Site | |
| Pretoria, South Africa, 0083 | |
| QdotPharma | |
| George, South Africa, 6529 | |
| Boehringer Ingelheim Investigational Site | |
| Durban, South Africa, 4001 | |
| Tiervlei Trial Centre | |
| Bellville, South Africa, 7530 | |
| Boehringer Ingelheim Investigational Site | |
| Paarl, South Africa, 7646 | |
| Boehringer Ingelheim Investigational Site | |
| Johannesburg, South Africa, 2193 | |
| Boehringer Ingelheim Investigational Site | |
| Cape Town, South Africa, 8001 | |
| St. Augustine Hospital | |
| Durban, South Africa, 4001 | |
| UCT Lung Institute | |
| Cape Town, South Africa, 7700 | |
| Boehringer Ingelheim Investigational Site | |
| Bloemfontein, South Africa, 9301 | |
| Sweden | |
| Lung och allergikliniken | |
| Stockholm, Sweden, 141 86 | |
| Lung- och allergikliniken, Universitetssjukhuset | |
| Umeå, Sweden, S-901 85 | |
| Lung- och allergikliniken, Länssjukhuset Ryhov | |
| Jönköping, Sweden, S-551 85 | |
| Endokrinologmott/Medicinkliniken | |
| Motala, Sweden, 591 85 | |
| Lung och allergikliniken | |
| Stockholm, Sweden, 171 76 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharma GmbH & Co. KG |
More Information
| Study ID Numbers: | 205.287 |
| Study First Received: | October 14, 2005 |
| Last Updated: | September 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00239421 History of Changes |
| 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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Anti-Inflammatory Agents Parasympatholytics Respiratory System Agents Disease Attributes Neurotransmitter Agents Cholinergic Antagonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cholinergic Agents Adrenergic Agonists Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Therapeutic Uses |
Fluticasone Formoterol Tiotropium Dermatologic Agents Salmeterol Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Chronic Disease Peripheral Nervous System Agents Bronchodilator Agents |