We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00274066
First Posted: January 10, 2006
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  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
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Peak FEV1 response, defined as the peak FEV1 minus the steady-state baseline FEV [ Time Frame: up to 37 days ]

Secondary Outcome Measures:
  • 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 ]
  • FEV1 and FVC response one hour after the second dose of randomised treatment [ Time Frame: up to 37 days ]
  • Individual FEV1 and FVC measurements at each time point [ Time Frame: 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 ]
  • All adverse events [ Time Frame: up to 37 days ]
  • Pulse rate [ Time Frame: up to 37 days ]
  • Sitting blood pressure in conjunction with spirometry [ Time Frame: up to 37 days ]
  • ECG recorded one hour after the first dose of randomised treatment [ Time Frame: 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 ]

Estimated Enrollment: 65
Study Start Date: October 2002
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 bronchiectasis; tuberculosis
  • pulmonary resection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274066


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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar
  More Information

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
First Submitted: January 9, 2006
First Posted: January 10, 2006
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Ipratropium
Fenoterol
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents


To Top