Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00274066
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To evaluate acute effect of single dose of ipratropium (Atrovent) or fenoterol (Berotec) in comparison to placebo when given to COPD patients on pharmacodynamic steady state of tiotropium (Spiriva)

Detailed Description

In case mono-bronchodilator therapy does not control symptoms of COPD adequately or if regular maintenance therapy is desired, a therapeutic intervention with a combination of bronchodilators is recommended. The risks of side-effects increases with increasing dose of any drug and, therefore, the most important rationale for combination therapy is a very favourable ratio of efficacy and safety. Knowing that anticholinergic and beta-adrenergic agents achieve their bronchodilating effects by different mechanisms, in particular the combination of these agents has proven to be beneficial in the management of COPD. Based on the established clinical benefits, tiotropium is an attractive and promising agent for the first-line long-term maintenance therapy in COPD. This also implies that a therapeutic intervention with other bronchodilators will be prescribed in daily practice. At present no studies on combination therapy with short-acting agents are available. Therefore, using a double-blind, randomised, crossover design, the bronchodilator effects of single doses of ipratropium or fenoterol were compared with placebo when added on top of steady state tiotropium. Patients were pre-treated with tiotropium to achieve this pharmacodynamic steady state. Serial lung function tests (FEV1, FVC, Raw, sGaw) were conducted following add-on of the short-acting bronchodilators or placebo.

Study Hypothesis:

H0: there is no difference between treatments in mean peak FEV1 H1: there is a difference between treatments in mean peak FEV1

Comparison(s):

Add-on of placebo was compared to add-on of ipratropium or add-on of fenoterol. The comparison of ipratropium with placebo was primary. The other 2 pair-wise comparisons were secondary.

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Peak FEV1 response, defined as the peak FEV1 minus the steady-state baseline FEV	up to 37 days

Secondary Outcome Measures

Name	Time	Method
FEV1 and FVC response one hour after the second dose of randomised treatment	up to 37 days
Individual FEV1 and FVC measurements at each time point	up to 37 days
Peak FVC response in the six-hour observation period following administration of the first single dose of randomised treatment	up to 37 days
sGaw and Raw measured at 1 and 6 hour after the first dose of randomised treatment and at 1 hour after the second dose of randomised treatment	up to 37 days
All adverse events	up to 37 days
Pulse rate	up to 37 days
Sitting blood pressure in conjunction with spirometry	up to 37 days
ECG recorded one hour after the first dose of randomised treatment	up to 37 days
Physical examination at baseline (Visit 1) and at the conclusion of patient participation in the trial	up to 37 days

Trial Locations

Locations (5)

Afdeling longziekten; 🇳🇱 Winschoten, Netherlands

Twenteborg Ziekenhuis; 🇳🇱 Almelo, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

Boehringer Ingelheim Investigational Site; 🇳🇱 Groningen, Netherlands

Gelre Ziekenhuizen; 🇳🇱 Zutphen, Netherlands