Effects of Symbicort on the Ventilatory Kinematics
Condition: Chronic Obstructive Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Budesonide; Symbicort
Intervention description: budesonide 80 mcg; A combination of budesonide and long acting beta agonist: Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: COPD; Chronic Obstructive Lung Disease; Long acting beta agonist

Summary:

      The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate
      (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using
      Optoelectronic Plethysmography (OEP). This study is unique as it will be the first
      randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol
      fumarate dihydrate as the intervention which will evaluate the effects on ventilatory
      mechanics through the use of OEP. The investigators plan to demonstrate that
      budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected
      with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short
      term on exercise capacity during a constant load exercise test. The changes in ventilatory
      mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a
      unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also
      demonstrating the utility of OEP in evaluating of the effects of a medical treatment on
      hyperinflation in individuals with chronic obstructive lung disease (COPD).

        1. Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and
           post exercise spirometry and evaluate exercise dynamic hyperinflation before and after
           treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate
           dihydrate will decrease dynamic hyperinflation as measured by OEP.

        2. Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation,
           specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical
           breathing as measured by OEP.

        3. Secondary Objective: Our secondary objective is to evaluate duration of steady state
           exercise and exercise capacity before and after treatment. Our secondary hypothesis is
           that decreases in dynamic hyperinflation during exercise will lead to improvements in
           dyspnea with exercise, and allow for increases in exercise capacity.

        4. Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady
           state vs. Borg at end exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe COPD by Global Initiative for Chronic Obstructive Lung Disease
             (GOLD) criteria

          -  Approval by pulmonologist

          -  Informed consent

          -  Age 40 to 75

          -  Males and females

          -  All races

          -  Ex smoker or non smoker

          -  Prior therapy allowed

        Exclusion Criteria:

          -  No active cardiac disease

          -  Alpha1 Antitrypsin Deficiency

          -  Active smoking

          -  Reactive Airways Disease

          -  Pulmonary Hypertension

          -  Comorbid conditions preventing exercise (arthritic, neurologic, vascular, or other
             conditions)

          -  BMI>30

          -  Current enrollment in any other concurrent study at Columbia University Medical Center
             or sponsored by AstraZeneca at any other sites

          -  Participation in any pharmacologic studies in the last 6 months prior to enrollment in
             this study