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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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: NCT00239447
• Other study ID #: 205.249
• Status: Completed
• Phase: Phase 3
• Start date: November 26, 2002
• Est. completion date: April 29, 2004

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 29, 2004
• Est. primary completion date: April 29, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

• All patients had to sign an informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.

• All patients had to have a diagnosis of chronic obstructive pulmonary disease.

• Patients had to have relatively stable, moderate to severe airway obstruction with an forced expiratory volume in one second (FEV1) = 60% of predicted normal and FEV1 = 70% of forced vital capacity FVC (Visits 1 and 2).

• Male or female patients 40 years of age or older.

• Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years.

• Patients had to be able to perform technically acceptable pulmonary function tests and peak expiratory flow rate (PEFR) measurements, and had to be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol.

• Patients had to be able to inhale medication in a competent manner from the Respimat inhaler, the HandiHaler and from a metered dose inhaler (MDI).

Exclusion criteria:

• Patients with significant diseases other than chronic obstructive pulmonary disease (COPD) had to be excluded. A significant disease was defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.

• Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.

• Patients with a recent history (i.e., one year or less) of myocardial infarction.

• Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years.

• Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.

• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.

• Patients with known narrow-angle glaucoma.

• Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count =600 mm3.

• Further exclusion criteria apply

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium

Device:
• HandiHaler

• Respimat SMI

Locations

Country	Name	City	State
Canada	Montreal Chest Institute - McGill University Health Centre	Montreal	Quebec
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Division of Pulmonary and Critical Care Medicine	Little Rock	Arkansas
United States	Minisota Lung Center	Minneapolis	Minnesota
United States	Boehringer Ingelheim Investigational Site	San Diego	California
United States	San Jose Clinical Research	San Jose	California
United States	LSU MC-Sheveport	Shreveport	Louisiana
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Boehringer Ingelheim Investigational Site	Stockton	California
United States	Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough FEV1 response determined at the end of each 4-week period of randomised treatment.		at the end of each 4-week period
Secondary	Tiotropium plasma concentration data and urinary excretion data		at the end of each 4-week period
Secondary	Trough forced vital capacity (FVC) response		after 4 weeks
Secondary	Peak response (FEV1 and FVC)		within 3 hours after first dose, after 4 weeks
Secondary	FEV1 AUC 0-12h and FVC AUC 0-12h response		after 4 weeks
Secondary	FEV1 AUC 0-3h and FVC AUC 0-3h response		after the first dose, after 4 weeks
Secondary	Individual FEV1and FVC measurements		during study course of 28 weeks
Secondary	pre-dose morning and evening peak expiratory flow rate (PEFR)		during study course of 28 weeks
Secondary	Number of occasions of rescue therapy used		during study course of 28 weeks
Secondary	Median time to onset of therapeutic response after first dose (FEV1)		after first dose and after 4 weeks
Secondary	Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks		up to 28 weeks