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

October 31, 2013 updated by: Boehringer Ingelheim

The Acute Bronchodilator Effects of a Single Dose (2 Puffs) of the Shortacting Anticholinergic Ipratropium Bromide (40μg) and the Short-acting Beta-adrenergic Fenoterol (200μg) in Comparison to Placebo on Top of Pharmacodynamic Steady State of Once Daily Tiotropium (18μg) Inhalation Capsule in Patients With Chronic Pulmonary Disease (COPD)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • Twenteborg Ziekenhuis
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis
      • Groningen, Netherlands, 9700 RB
        • Boehringer Ingelheim Investigational Site
      • Winschoten, Netherlands, 9670 RA
        • Afdeling longziekten
      • Zutphen, Netherlands, 7207 BA
        • Gelre Ziekenhuizen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • diagnosis of COPD
  • FEV1 < 60% of predicted
  • FEV1 < 70% of FVC
  • smoking history of 10 pack-years

Exclusion:

  • significant other disease than COPD
  • history of asthma, allergic rhinitis or blood eosinophil count > 600mm3
  • cardiac arrhythmia requiring drug therapy
  • symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
  • recent history of MI (within past year)
  • history of cancer within past 5 years
  • life-threatening pulmonary obstruction
  • cystic fibrosis or bronchiectasis; tuberculosis
  • pulmonary resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak FEV1 response, defined as the peak FEV1 minus the steady-state baseline FEV
Time Frame: up to 37 days
up to 37 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 9, 2006

First Posted (Estimate)

January 10, 2006

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.258

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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