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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281567
• Other study ID #: 205.250
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2006
• Last updated: October 31, 2013
• Start date: August 2002

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium

Device:
• Respimat SMI

• HandiHaler

Locations

Country	Name	City	State
Belgium	Boehringer Ingelheim Investigational Site	Study chairs or principal investigators
Netherlands	Boehringer Ingelheim Investigational Site	Study chairs or principal investigators

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)		baseline until week 28	No
Secondary	Peak response (FEV1 and FVC) to first dose		within 3 hours to first dose	No
Secondary	Peak response (FEV1 and FVC) after 4 weeks		within 3 hours after 4 weeks	No
Secondary	FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks		after 4 weeks	No
Secondary	FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks		after first dose and after 4 weeks	No
Secondary	Individual FEV1and FVC measurements at each time point		up to 28 weeks	No
Secondary	Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients		up to 28 weeks	No
Secondary	Number of occasions of rescue therapy used as required (p.r.n. salbutamol)		up to 28 weeks	No
Secondary	Median time to onset of therapeutic response after first dose		after 4 weeks	No
Secondary	Number of patients with 15% response above baseline for each treatment at each timepoint after first dose		at week 4, 12, 20	No
Secondary	Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks		at week 8, 16, 24	No

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