Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium + placebo Drug: Tiotropium + ipratropium Drug: Tiotropium + fenoterol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | The Acute Bronchodilator Effects of a Single Dose (2 Puffs) of the Short-acting Anticholinergic Ipratropium Bromide (40 Mcg) and the Short-acting Beta-adrenergic Fenoterol (200 Mcg) in Comparison to Placebo on Top of Pharmacodynamic Steady State of Once-daily Tiotropium (18 Mcg) Inhalation Capsule in |
- In terms of peak as well as duration of the bronchodilatory effect, add-on therapy of fenoterol on top of tiotropium was found to be superior compared to added ipratropium.
- The safety profile indicates that adding single doses of fenoterol or ipratropium to steady state of tiotropium is safe and well tolerated.
| Estimated Enrollment: | 64 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | September 2003 |
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Netherlands | |
| Twenteborg Ziekenhuis | |
| Almelo, Netherlands, 7609 PP | |
| Amphia Ziekenhuis | |
| Breda, Netherlands, 4819 EV | |
| Boehringer Ingelheim Investigational Site | |
| Groningen, Netherlands, 9700 RB | |
| Afdeling longziekten | |
| Winschoten, Netherlands, 9670 RA | |
| Gelre Ziekenhuizen | |
| Zutphen, Netherlands, 7207 BA | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim BV/Alkmaar |
More Information
Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00274066 History of Changes |
| Other Study ID Numbers: | 205.258 |
| Study First Received: | January 9, 2006 |
| Last Updated: | May 14, 2012 |
| Health Authority: | Netherlands: IGZ Health Inspection |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive Fenoterol Bronchodilator Agents Ipratropium Tiotropium Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013