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

NCT ID: NCT00274066

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2003-09-30

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Tiotropium + placebo

Intervention Type: DRUG

Tiotropium + ipratropium

Intervention Type: DRUG

Tiotropium + fenoterol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim BV/Alkmaar

Locations

Twenteborg Ziekenhuis

Almelo, , Netherlands

Amphia Ziekenhuis

Breda, , Netherlands

Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

Afdeling longziekten

Winschoten, , Netherlands

Gelre Ziekenhuizen

Zutphen, , Netherlands

Countries

Netherlands

References

Kerstjens HA, Bantje TA, Luursema PB, Sinninghe Damste HE, de Jong JW, Lee A, Wijker SP, Cornelissen PJ. Effects of short-acting bronchodilators added to maintenance tiotropium therapy. Chest. 2007 Nov;132(5):1493-9. doi: 10.1378/chest.06-3059. Epub 2007 Sep 21.

Reference Type: DERIVED

PMID: 17890476 (View on PubMed)

Other Identifiers

205.258

Identifier Type: -

Identifier Source: org_study_id