Clinical trial NCT00281567: Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-25
Enrollment: 76
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* FEV1 \< 60% predicted
* FEV1 \< 70% of FVC
* Smoking history of 10 pack-years

Exclusion Criteria:

* Significant other disease than COPD
* Recent history of MI (1 year or less)
* Cardiac arrhythmia requiring drug therapy
* History of asthma, allergic rhinitis or eosinophil count \> 600 mm3
* Symptomatic prostatic hypertrophy or bladder neck obstruction
* Known narrow-angle glaucoma
* Abnormal baseline hematology, blood chemistry or urinalysis
* History of cancer within last 5 years
* Life-threatening pulmonary obstruction
* Cystic fibrosis or bronchiectasis
* Tuberculosis
* Pulmonary resection

Primary outcomes:
measure: Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
Secondary outcomes:
measure: Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)
timeFrame: baseline until week 28
measure: Peak response (FEV1 and FVC) to first dose
timeFrame: within 3 hours to first dose
measure: Peak response (FEV1 and FVC) after 4 weeks
timeFrame: within 3 hours after 4 weeks
measure: FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks
timeFrame: after 4 weeks
measure: FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks
timeFrame: after first dose and after 4 weeks
measure: Individual FEV1and FVC measurements at each time point
timeFrame: up to 28 weeks
measure: Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients
timeFrame: up to 28 weeks
measure: Number of occasions of rescue therapy used as required (p.r.n. salbutamol)
timeFrame: up to 28 weeks
measure: Median time to onset of therapeutic response after first dose
timeFrame: after 4 weeks
measure: Number of patients with 15% response above baseline for each treatment at each timepoint after first dose
timeFrame: at week 4, 12, 20
measure: Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks
timeFrame: at week 8, 16, 24
Other outcomes:
Locations:
city: Study chairs or principal investigators
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Study chairs or principal investigators
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim KG
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: