Effects of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention description(s): Nebulized Budesonide (4 mL) or saline solution (0.9% NaCl) (4 mL) will be administered to subjects once only.
Other intervention name(s): Pulmicort
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Pulmicort; Budesonide; Chronic; Obstructive; Pulmonary; Disease; Exercise; Emphysema