Study to Assess the Effect of Salbutamol and Ipratropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00911651
First received: May 28, 2009
Last updated: June 1, 2009
Last verified: May 2009
  Purpose

The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances for both compounds.


Condition Intervention Phase
COPD
Drug: Salbutamol
Drug: ipratropium bromide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Randomized, Two-Way Crossover, Pilot Study to Assess the Effect of Salbutamol in Comparison With Ipratropium Bromide on Central and Peripheral Airway Dimensions in COPD Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • The primary objective of this study is to assess the effect of a single dose of salbutamol in comparison with ipratropium bromide on central and peripheral small airways with high-resolution/multislice CT scan imaging technique. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objectives are to evaluate effects on spirometric indices to correlate these with the CFD based calculated airway volumes and resistances for both compounds and to evaluate the safety of the products. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: salbutamol
6 patients with moderate (GOLD 2) and severe (GOLD 3) COPD
Drug: Salbutamol
400 µg inhalation once
Other Name: Ventolin
Active Comparator: ipratropium bromide
COPD patients GOLD stage II and III
Drug: ipratropium bromide
80 µg inhalation once
Other Name: atrovent

Detailed Description:

Salbutamol (VentolinTM) is a short acting beta agonist (SABA) which is used to treat wheezing, dyspnea and breathing difficulties caused by asthma and COPD. Further, it is also used to prevent bronchospasm during exercise.

Ipratropium bromide (Atrovent® HFA) is a short acting anticholinergic bronchodilator (short acting muscarinic antagonist (SAMA)) that improves lung function, dyspnea, exercise tolerance and health-related quality of life in patients with COPD. Studies have also shown that ipratropium bromide might reduce COPD exacerbations and related hospitalisations because the extended bronchodilatation might reduce infection rates by improving clearance of respiratory secretions.

In this open, randomized, two-way crossover, pilot study the effect of salbutamol in patients with moderate and severe COPD will be examined in comparison with the effects of ipratropium bromide. These patients will receive 400 µg salbutamol and 80 µg ipratropium bromide in a randomized crossover design.

The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices (as Forced Expiratory Volume in one second (FEV1) and Tiffeneau index) with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances for both compounds.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with documented COPD based on the following criteria:

    • Smoking history of at least 10 pack-years.
    • Decreased Tiffeneau index (FEV1/(F)VC < 0.70).
  2. Patients aged ≥ 40 years.
  3. Patients should present moderate to severe COPD with an FEV1 between 30 and 80% of predicted (GOLD 2 and 3).
  4. Patients should be treated according to GOLD guidelines.
  5. Able to inhale study drug.
  6. Maintained on stable respiratory medications for 6 weeks prior to visit 1.
  7. Able to perform lung function tests.
  8. Able to follow study procedures.

Exclusion Criteria:

  1. Patients who are allergic to salbutamol, ipratropium bromide or to another element of the product.
  2. Patients allergic to sojalecithin and products on the basis of soja and peanut.
  3. Patients who have or ever had glaucoma.
  4. Patients with urinary problems, prostate hyperplasy or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
  5. Patients with a recent history (i.e. six months or less) of myocardial infarction.
  6. Patients with any unstable or life threatening cardiac arrhythmia.
  7. Patients with severe kidney insufficiency (creatinine clearance ≤50 ml/min)a.
  8. Patients below the age of 40.
  9. Patients who are pregnant or are breast-feeding.
  10. Patients who are treated with other anticholinergic medications, that cannot be stopped during the study period.
  11. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
  12. Significant alcohol or drug abuse within the past 12 months.
  13. Participation in another trial with an investigational drug within one month or six half lives (whichever is greater) prior to screening visit.
  14. Known active tuberculosis.
  15. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
  16. A history of thoracotomy with pulmonary resection.
  17. Active or untreated malignancy.
  18. Use of oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses ≥ 10 mg/day.

a Cockroft's formulae should be applied: in male: creatinine clearance = (140-age) x weight / 72 x creatininemia in female: creatinine clearance = 0.85 x (140-age) x weight / 72 x creatininemia

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911651

Locations
Belgium
Antwerp University Hospital
Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
GlaxoSmithKline
Investigators
Principal Investigator: Wilfried A De Backer, MD PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Prof Wilfried De Backer, Antwerp University Hospital
ClinicalTrials.gov Identifier: NCT00911651     History of Changes
Other Study ID Numbers: PML_DOC_0801
Study First Received: May 28, 2009
Last Updated: June 1, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
COPD
salbutamol
ipratropium bromide
computational fluid dynamics
functional imaging
central and peripheral airways

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Bromides
Albuterol
Ipratropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
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 September 18, 2014