Pharmacokinetics and dose-ranging of tiotropium inhalation solution delivered from the Respimat inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Completed

Conditions: emphysema
10038716
chronic bronchitis

Registration Number: NL-OMON34309

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

1. All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, including medication washout and restrictions.
2. Male or female patients 40 years of age or older.
3. Patients must be current or ex-smokers with a smoking history of at least 10 pack-years.
4. All patients must have a diagnosis of COPD (refer to page 22 of study protocol).
5. Patients must be able to perform technically acceptable pulmonary function tests.
6. Patients must be able to inhale medication in a competent manner from the Respimat and HandiHaler devices.

Exclusion Criteria

1. Significant diseases other than COPD (refer to page 23 of study protocol).
2. Patients with a recent history of myocardial infarction.
3. Patients with any unstable of life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the past year.
4. Hospitalisation for cardiac failure during the past year.
5. Patients with a history of asthma or who have a total eosinophil count equal to or above 600/mm3.
6. Use of systemic corticosteroid medication at unstable doses (less than 6 weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day.
7. Pregnant or nursing women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The systemic availability after inhalation of different tiotropium doses will<br /><br>be assessed by the following primary endpointrs:<br /><br>- Cmax,ss = maximum tiotropium concentration in plasma in steady state<br /><br>condition,<br /><br>- AUC(0-6),ss = area under the tiotropium concentration-time curve in plasma in<br /><br>steady state condition for the time interval till 6 hours post inhalation. </p><br>

Secondary Outcome Measures