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

NCT00911651 | Completed Phase 4 DMC

• 1 other identifier: PML_DOC_0801
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Keywords

COPD; salbutamol; ipratropium bromide; computational fluid dynamics; functional imaging; central and peripheral airways

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (1)

• 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.

  1 month

Study Arms (2)

salbutamol

ACTIVE COMPARATOR

6 patients with moderate (GOLD 2) and severe (GOLD 3) COPD

Drug: Salbutamol

ipratropium bromide

ACTIVE COMPARATOR

COPD patients GOLD stage II and III

Drug: ipratropium bromide

Interventions

Salbutamol DRUG

400 µg inhalation once

Also known as: Ventolin

salbutamol

ipratropium bromide DRUG

80 µg inhalation once

Also known as: atrovent

ipratropium bromide

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients aged ≥ 40 years.
• Patients should present moderate to severe COPD with an FEV1 between 30 and 80% of predicted (GOLD 2 and 3).
• Patients should be treated according to GOLD guidelines.
• Able to inhale study drug.
• Maintained on stable respiratory medications for 6 weeks prior to visit 1.
• Able to perform lung function tests.
• Able to follow study procedures.

You may not qualify if:

• Patients who are allergic to salbutamol, ipratropium bromide or to another element of the product.
• Patients allergic to sojalecithin and products on the basis of soja and peanut.
• Patients who have or ever had glaucoma.
• Patients with urinary problems, prostate hyperplasy or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
• Patients with a recent history (i.e. six months or less) of myocardial infarction.
• Patients with any unstable or life threatening cardiac arrhythmia.
• Patients with severe kidney insufficiency (creatinine clearance ≤50 ml/min)a.
• Patients below the age of 40.
• Patients who are pregnant or are breast-feeding.
• Patients who are treated with other anticholinergic medications, that cannot be stopped during the study period.
• A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
• Significant alcohol or drug abuse within the past 12 months.
• Participation in another trial with an investigational drug within one month or six half lives (whichever is greater) prior to screening visit.
• Known active tuberculosis.
• A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Antwerp University Hospital

Antwerp, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol; Ipratropium

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Wilfried A De Backer, MD PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 2, 2009
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: June 2, 2009

Record last verified: 2009-05

Locations

BE (1)