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

Completed · Phase 3

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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

Key facts

Study ID

NCT00239447

Run by

Boehringer Ingelheim

People needed

131

Starts

2002-11-26

Expected to finish

2004-04-29

Last updated by the study team

2023-12-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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