Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)

Phase 3CompletedNCT00281567

Boehringer Ingelheim76 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

TiotropiumDRUG

Respimat SMIDEVICE

HandiHalerDEVICE

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (2)

Boehringer Ingelheim Investigational Site

Study Chairs Or Principal Investigators, Belgium

Boehringer Ingelheim Investigational Site

Study Chairs Or Principal Investigators, Netherlands

Outcomes

Primary Outcomes

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

Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)

Time frame: baseline until week 28

Peak response (FEV1 and FVC) to first dose

Time frame: within 3 hours to first dose

Peak response (FEV1 and FVC) after 4 weeks

Time frame: within 3 hours after 4 weeks

FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks

Time frame: after 4 weeks

FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks

Time frame: after first dose and after 4 weeks

Individual FEV1and FVC measurements at each time point

Time frame: up to 28 weeks

Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients

Time frame: up to 28 weeks

Number of occasions of rescue therapy used as required (p.r.n. salbutamol)

Time frame: up to 28 weeks

Median time to onset of therapeutic response after first dose

Time frame: after 4 weeks

Number of patients with 15% response above baseline for each treatment at each timepoint after first dose

Data from ClinicalTrials.gov

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