Effects of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00202189

Last Updated: 2008-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2005-11-30

Brief Summary

Human and animal studies have shown that inhaled corticosteroids (ICS) decrease airway blood flow . This effect is immediate (within 30 minutes), transient (lasting 90 minutes), and in animal studies independent of gene expression. In COPD patients, decrease in bronchial blood flow may also decrease mucosal edema, airway resistance and improve small airway function. If such an effect exists, then we should be able to measure improvements in airway conductance and reduce lung hyperinflation, which would have salutary effects on dyspnea and exercise endurance.

To our knowledge, no study has examined the immediate effect of ICS on small airway function in COPD. The purpose of this study is to examine the effects of nebulized Pulmicort on small airway function (spirometry, plethysmographic lung volumes, airways resistance, closing volume, partial flow-volume loop analysis) and exercise endurance in patients with moderate to severe COPD.

HYPOTHESIS

1. Nebulized ICS will immediately improve airway function compared with placebo (nebulized saline).

2. Enhanced lung emptying and reduced operating lung volumes during rest and exercise following ICS therapy will translate acutely into clinically important reductions in exertional dyspnea and improvements in exercise endurance.

Detailed Description

This will be a single site, pilot, randomized, double-blinded, placebo-controlled, cross-over study that will be conducted at this centre. Subjects will be required to complete four (4) visits to the laboratory over a one-month period.

At Visit 1, subjects who meet all study inclusion and exclusion criteria, will have a full set of pulmonary function tests (PFT) done and complete a symptom-limited incremental cycle exercise test. At Visit 2, subjects will have a partial set of pulmonary function tests (PFT) done and complete a symptom-limited constant load cycle exercise test. On the third and fourth visit subjects will be randomized to treatment with either nebulized saline or nebulized Pulmicort® in a double blinded, cross-over design, subsequent to which they will have their PFT's and symptom limited constant load exercise testing done.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Pulmicort; Budesonide; Chronic; Obstructive; Pulmonary; Disease; Exercise; Emphysema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Budesonide

Group Type: EXPERIMENTAL

Budesonide

Intervention Type: DRUG

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

2

Saline Solution (0.9% NaCl)

Group Type: PLACEBO_COMPARATOR

Budesonide

Intervention Type: DRUG

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

Interventions

Budesonide

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

Intervention Type: DRUG

Other Intervention Names

Pulmicort

Eligibility Criteria

Inclusion Criteria

• FEV1 less than/equal to 70 % predicted, FEV1/FVC ratio less than/equal to 70%, and FRC greater than/equal to 120 % predicted
• Moderate to severe chronic activity-related dyspnea (modified Baseline Dyspnea Index focal score less than/equal to 6)
• Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding four weeks
• Males or females greater than 40 years of age;
• A cigarette smoking history of at least 20 pack-years
• Able to perform all study procedures and sign informed consent

Exclusion Criteria

• History of asthma, atopy or nasal polyps
• Recent history of cardiovascular disease (< 1 year) or other significant disease that could contribute to dyspnea or exercise limitation
• Oxygen saturation less than 80% during exercise on room air

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Queen's University

Principal Investigators

Denis E O'Donnell, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University-Respiratory Investigation Unit

Locations

Respiratory Investigation Unit

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

DMED-892-05

Identifier Type: -

Identifier Source: org_study_id