Clinical trial NCT00239447: Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 131
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.
* Further exclusion criteria apply

Primary outcomes:
measure: Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
timeFrame: at the end of each 4-week period
Secondary outcomes:
measure: Tiotropium plasma concentration data and urinary excretion data
timeFrame: at the end of each 4-week period
measure: Trough forced vital capacity (FVC) response
timeFrame: after 4 weeks
measure: Peak response (FEV1 and FVC)
timeFrame: within 3 hours after first dose, after 4 weeks
measure: FEV1 AUC 0-12h and FVC AUC 0-12h response
timeFrame: after 4 weeks
measure: FEV1 AUC 0-3h and FVC AUC 0-3h response
timeFrame: after the first dose, after 4 weeks
measure: Individual FEV1and FVC measurements
timeFrame: during study course of 28 weeks
measure: pre-dose morning and evening peak expiratory flow rate (PEFR)
timeFrame: during study course of 28 weeks
measure: Number of occasions of rescue therapy used
timeFrame: during study course of 28 weeks
measure: Median time to onset of therapeutic response after first dose (FEV1)
timeFrame: after first dose and after 4 weeks
measure: Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks
timeFrame: up to 28 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Division of Pulmonary and Critical Care Medicine
state: Arkansas
city: San Diego
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: San Jose
country: United States
facility: San Jose Clinical Research
state: California
city: Stockton
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Shreveport
country: United States
facility: LSU MC-Sheveport
state: Louisiana
city: Minneapolis
country: United States
facility: Minisota Lung Center
state: Minnesota
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Tacoma
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
city: Montreal
country: Canada
facility: Montreal Chest Institute - McGill University Health Centre
state: Quebec
Study officials:
affiliation: Boehringer Ingelheim BV/Alkmaar
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: