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

NCT ID: NCT00239447

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-26
• Study Completion Date: 2004-04-29

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Tiotropium

Intervention Type: DRUG

HandiHaler

Intervention Type: DEVICE

Respimat SMI

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim BV/Alkmaar

Locations

Division of Pulmonary and Critical Care Medicine

Little Rock, Arkansas, United States

Boehringer Ingelheim Investigational Site

San Diego, California, United States

San Jose Clinical Research

San Jose, California, United States

Boehringer Ingelheim Investigational Site

Stockton, California, United States

National Jewish Medical and Research Center

Denver, Colorado, United States

LSU MC-Sheveport

Shreveport, Louisiana, United States

Minisota Lung Center

Minneapolis, Minnesota, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Montreal Chest Institute - McGill University Health Centre

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

205.249

Identifier Type: -

Identifier Source: org_study_id