Effects of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsors and Collaborators:	Queen's University No collaborators. Study funded by investigator.
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00202189

Purpose

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

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

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Budesonide	Phase IV

MedlinePlus related topics: Breathing Problems COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness

Drug Information available for: Budesonide Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	Acute Effects of Inhaled Corticosteroids on Dynamic Airway Function During Rest and Exercise in Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by Queen's University:

Primary Outcome Measures:

endurance time [ Time Frame: 60 minutes post-inhalation ] [ Designated as safety issue: No ]
dyspnea [ Time Frame: 60-minutes post-inhalation ] [ Designated as safety issue: No ]

Enrollment:	4
Study Start Date:	September 2005
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Budesonide	Drug: Budesonide Nebulized Budesonide (4 mL) or saline solution (0.9% NaCl) (4 mL) will be administered to subjects once only.
2: Placebo Comparator Saline Solution (0.9% NaCl)	Drug: Budesonide Nebulized Budesonide (4 mL) or saline solution (0.9% NaCl) (4 mL) will be administered to subjects once only.

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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202189

Locations

Canada, Ontario
Respiratory Investigation Unit
Kingston, Ontario, Canada, K7L 2V7

Sponsors and Collaborators

Queen's University

No collaborators. Study funded by investigator.

Investigators

Principal Investigator:

Denis E O'Donnell, MD

Queen's University-Respiratory Investigation Unit

More Information

No publications provided

Responsible Party:	Queen's University ( Dr. Denis O'Donnell )
Study ID Numbers:	DMED-892-05
Study First Received:	September 9, 2005
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00202189 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

COPD
Pulmicort
Budesonide
Chronic
Obstructive

Pulmonary
Disease
Exercise
Emphysema

Study placed in the following topic categories:

Anti-Inflammatory Agents
Emphysema
Hormone Antagonists
Respiration Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Glucocorticoids

Hormones
Pulmonary Emphysema
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Respiration Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Hormones
Glucocorticoids

Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009