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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Device: HandiHaler

Drug: Tiotropium

Device: Respimat SMI

Study type

Interventional

Funder types

Industry

Identifiers

205.249

Details and patient eligibility

About

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

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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