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Completed

NCT Number: NCT00202189

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Disease Attributes Emphysema Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Respiratory Investigation Unit

Kingston, Ontario, K7L 2V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

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

Other names: Pulmicort

Primary outcomes

  1. endurance time

    Time frame: 60 minutes post-inhalation

  2. dyspnea

    Time frame: 60-minutes post-inhalation

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

Acute Effects of Inhaled Corticosteroids on Dynamic Airway Function During Rest and Exercise in Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Aug 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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