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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274066
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013

January 9, 2006
October 31, 2013
October 2002
September 2003   (final data collection date for primary outcome measure)
Peak FEV1 response, defined as the peak FEV1 minus the steady-state baseline FEV [ Time Frame: up to 37 days ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00274066 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • FEV1 and FVC response one hour after the second dose of randomised treatment [ Time Frame: up to 37 days ] [ Designated as safety issue: No ]
  • Individual FEV1 and FVC measurements at each time point [ Time Frame: up to 37 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: up to 37 days ] [ Designated as safety issue: No ]
  • Pulse rate [ Time Frame: up to 37 days ] [ Designated as safety issue: No ]
  • Sitting blood pressure in conjunction with spirometry [ Time Frame: up to 37 days ] [ Designated as safety issue: No ]
  • ECG recorded one hour after the first dose of randomised treatment [ Time Frame: up to 37 days ] [ Designated as safety issue: No ]
  • Physical examination at baseline (Visit 1) and at the conclusion of patient participation in the trial [ Time Frame: up to 37 days ] [ Designated as safety issue: No ]
The safety profile indicates that adding single doses of fenoterol or ipratropium to steady state of tiotropium is safe and well tolerated.
Not Provided
Not Provided
 
Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva
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)

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Tiotropium + placebo
  • Drug: Tiotropium + ipratropium
  • Drug: Tiotropium + fenoterol
Not Provided
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. Epub 2007 Sep 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
September 2003
September 2003   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00274066
205.258
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP