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

NCT00202189 | Completed Phase 4 DMC

• 1 other identifier: DMED-892-05
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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. 1.Nebulized ICS will immediately improve airway function compared with placebo (nebulized saline).
2. 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• endurance time

  60 minutes post-inhalation

• dyspnea

  60-minutes post-inhalation

Study Arms (2)

1

EXPERIMENTAL

Budesonide

Drug: Budesonide

2

PLACEBO COMPARATOR

Saline Solution (0.9% NaCl)

Drug: Budesonide

Interventions

Budesonide DRUG

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

Also known as: Pulmicort

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:

• 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

You may not qualify if:

• 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

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; Emphysema

Interventions

Budesonide

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: September 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: August 13, 2008

Record last verified: 2008-08

Locations

CA (1)