Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)

NCT00202176 | Completed Phase 4 DMC

• 1 other identifier: DMED-833-04
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest (lung hyperinflation). Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic; Obstructive; Pulmonary; Disease; COPD; Atrovent; Ipratropium; Bromide; Exercise; Dyspnea

Outcome Measures

Primary Outcomes (2)

• endurance time

  2 hours post-study drug inhalation

• dyspnea

  2 hours post-study drug inhalation

Study Arms (2)

1

EXPERIMENTAL

Ipratropium Bromide

Drug: Ipratropium Bromide

2

PLACEBO COMPARATOR

Saline Solution (0.9% NaCl)

Drug: Ipratropium Bromide

Interventions

Ipratropium Bromide DRUG

Nebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only.

Also known as: Atrovent

1; 2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of mild COPD OR healthy control subjects
• years old
• able to perform all study procedures
• Smoking history \> 10 pack years (for mild COPD) or smoking history \< 10 pack years (for healthy control subjects)

You may not qualify if:

• allergy to atrovent
• history of asthma, atopy or nasal polyps
• Oxygen desaturation \< 80 % during exercise
• recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Respiratory Investigation Unit

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiolitis Obliterans Syndrome; Disease; Motor Activity; Dyspnea

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Graft vs Host Disease; Immune System Diseases; Behavior; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Denis E O'Donnell, MD

  Queen's University-Respiratory Investigation Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 19, 2011

Record last verified: 2011-04

Locations

CA (1)