Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium + placebo (Drug); Tiotropium + ipratropium (Drug); Tiotropium + fenoterol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim BV/Alkmaar
Summary
To evalute 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)
Clinical Details
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-Adrnergic Fenoterol (200 Mcg) in Comparison to Placebo on Top of Pharmacodynamic Steady State of Once-Daily Tiotropium (18 Mcg) Inhalation Capsule in
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: The safety profile indicates that adding single doses of fenoterol or ipratropium to steady state of tiotropium is safe and well tolerated.
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 wit hother bronchodilators will be prescribed i ndaily practise. 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
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 bronchietasis; tuberculosis;
pulmonary resection.
Locations and Contacts
Boehringer Ingelheim Investigational Site, Groningen 9700 RB, Netherlands
Amphia Ziekenhuis, Breda 4819 EV, Netherlands
Afdeling longziekten, Winschoten 9670 RA, Netherlands
Gelre Ziekenhuizen, Zutphen 7207 BA, Netherlands
Twenteborg Ziekenhuis, Almelo 7609 PP, Netherlands
Additional Information
Starting date: October 2002
Ending date: September 2003
Last updated: April 2, 2008
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