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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00144196 |
To show that treatment with tiotropium(Spiriva) inhalation capsules (18 ?g q.d.) via HandiHaler? improves lung function in patients with mild COPD according to Swedish guidelines.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive |
Drug: tiotropium (Spiriva) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A 12-Week, Double-Blind,Randomised, Parallel-Group,, Multi-Centre Study Evaluating the Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines. |
Estimated Enrollment: | 250 |
Estimated Study Completion Date: | July 2005 |
Following an initial screening at the screening visit(Visit 1), patients enter a 2 week run-in period. Patients are allowed to take salbutamol (Ventoline, Diskus, 0.2 mg) prn as rescue medication and have to record their daily use of it on the Patient's Diary. Patients who meet all inclusion and none of the exclusion criteria at the check at Visit 2 will be randomised thereafter into the randomised treatment period of the study during which they will receive either tiotropium(Spiriva) or placebo in blinded fashion.
On Day 0 (Visit 2), the first administration of blinded study medication (tiotropium(Spiriva) or matching placebo) will be performed at the study site, after a pre-dose pulmonary function test (PFT) has been carried out. First administration of blinded study medication will be monitored by the investigator. Post dose PFTs will be performed at 30 min, 1 and 2 hours.
On Days 1 to 83 except Day 14, the blinded study medication will be self-administered by the patients at home. The patients will inhale one capsule (tiotropium)(Spiriva) or matching placebo) using the HandiHaler device once daily in the morning. The morning dose of the blinded study medication should be taken at approximately the same time each morning between 7:00 a.m. and 10:00 a.m.
At visit 3 and 4 PFTs will be performed predose and post dose at 30 minutes, 1 and 2 hours
Study Hypothesis:
The rationale of the study is to show that treatment with tiotropium (Spiriva) 18 ?g inhalation capsule via HandiHaler once daily improves FEV1 when compared with placebo in patients with mild COPD according to Swedish guidelines, i.e., a post-bronchodilator FEV1 < 60% of predicted normal and FEV1 < 70% of FVC.
Comparison(s):
One group will be treated with inhalation powder capsules of tiotropium (Spiriva), 18 micrograms once daily. The other group will be treated with matching placebo. Randomisation is 1:1
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Boehringer Ingelheim Investigational Site | |
Uppsala, Sweden, 754 27 | |
KvartersAkuten, Timmermansgatan 26 | |
Lule?, Sweden, 972 31 | |
Halsocentralen, Hans?kervagen 1A | |
Stugun, Sweden, 830 76 | |
Boehringer Ingelheim Investigational Site | |
Sunne, Sweden, 686 22 | |
Alno V?rdcentral, Raholmsvagen 24 | |
Sundsvall, Sweden, 865 31 | |
Boehringer Ingelheim Investigational Site | |
Hasselby, Sweden, 165 55 | |
Boehringer Ingelheim Investigational Site | |
Stockholm, Sweden, 114 86 | |
Boehringer Ingelheim Investigational Site | |
Motala, Sweden, 591 36 | |
Boehringer Ingelheim Investigational Site | |
?tvidaberg, Sweden, 597 26 | |
Boehringer Ingelheim Investigational Site | |
Goteborg, Sweden, 411 53 | |
Boehringer Ingelheim Investigational Site | |
Dalum, Sweden, 520 25 | |
Boehringer Ingelheim Investigational Site | |
Ulricehamn, Sweden, 523 26 | |
Boehringer Ingelheim Investigational Site | |
Kalmar, Sweden, 393 50 | |
Boehringer Ingelheim Investigational Site | |
Gislaved, Sweden, 332 30 | |
Boehringer Ingelheim Investigational Site | |
Kristianstad, Sweden, 291 38 | |
Boehringer Ingelheim Investigational Site | |
Helsingborg, Sweden, 254 43 | |
Boehringer Ingelheim Investigational Site | |
Hollviken, Sweden, 236 51 | |
Boehringer Ingelheim Investigational Site | |
Skarholmen, Sweden, 127 37 | |
Jakobsbergs sjukhus, Birgittavagen 4 | |
Jarfalla, Sweden, 17731 | |
Boehringer Ingelheim Investigational Site | |
Karlstad, Sweden, 65224 | |
Boehringer Ingelheim Investigational Site | |
Helsingborg, Sweden, 254 67 | |
Boehringer Ingelheim Investigational Site | |
Linkoping, Sweden, 581 88 | |
Boehringer Ingelheim Investigational Site | |
Lund, Sweden, 221 85 | |
Boehringer Ingelheim Investigational Site | |
Boden, Sweden, 961 44 | |
Boehringer Ingelheim Investigational Site | |
Lule?, Sweden, 971 89 | |
Boehringer Ingelheim Investigational Site | |
Goteborg, Sweden, 416 65 | |
Boehringer Ingelheim Investigational Site | |
Alvesta, Sweden, 342 36 |
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Sweden AB |
Study ID Numbers: | 205.281 |
Study First Received: | September 2, 2005 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00144196 |
Health Authority: | Sweden: Medical Products Agency |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Chronic Disease Tiotropium Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Parasympatholytics Disease Attributes Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Cholinergic Agents Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |