Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

Overview

The main objective of the study is to see if using anti-inflammatory to patients with airway disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than using these treatments in patients with loss of lung tissue. Symbicort plus ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with airway predominant COPD.

Full Title of Study: “COPDGene Ancillary Proposal: Symbicort Intervention in “Airway Predominant”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2015

Detailed Description

Subjects from the COPDGene study who have airway-predominant COPD on chest CT scan will be enrolled; a total of 40 subjects is planned.

Subjects will all have background ipratropium-albuterol administered four times daily. Subjects will be randomized to receive budesonide (180 ug twice daily) or formoterol-budesonide (160/4.5 ug twice daily) for 12 weeks.

The main objective is to explore novel outcomes: blood biomarkers and chest CT scan. Outcomes include lung function, walk distance, respiratory disease-specific health status, and expiratory chest CT scan gas trapping as an exploratory outcome.

The primary outcome measure will be FEV1 pre-bronchodilator 12 hours after the last dose of study medication at the end of 12 weeks of treatment. FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose of budesonide and budesonide/formoterol

Interventions

  • Drug: Budesonide
    • Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed
  • Drug: budesonide/formoterol
    • Inhaled budesonide/formoterol (160/4.5 mcg Symbicort┬«) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent┬«) 1 puff four times daily
  • Drug: Ipratropium/albuterol
    • Inhaled ipratropium/albuterol combination 2 puffs four times daily

Arms, Groups and Cohorts

  • Active Comparator: ipratropium/albuterol
    • 1 puff 4 times daily
  • Experimental: Budesonide
    • budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
  • Experimental: budesonide/formoterol
    • budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily

Clinical Trial Outcome Measures

Primary Measures

  • Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
    • Time Frame: 12 weeks
    • FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose budesonide and budesonide/formoterol

Secondary Measures

  • Health Status
    • Time Frame: 12 weeks
    • Administer St. George’s Respiratory Questionnaire at randomization and 12 weeks.
  • Dyspnea
    • Time Frame: 12 weeks
    • Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.
  • Six minute walk distance
    • Time Frame: 12 weeks
    • Evaluate six minute walk distance at randomization and 12 weeks
  • Forced vital capacity (FVC) pre-bronchodilator
    • Time Frame: 12 weeks
  • Post-bronchodilator FEV1
    • Time Frame: 12 weeks
  • Patient-reported exacerbations
    • Time Frame: 12 weeks
  • Patient reported adverse events
    • Time Frame: 12 weeks
  • Post-bronchodilator FVC
    • Time Frame: 12 weeks
  • CT scan gas trapping
    • Time Frame: Before and 12 weeks after randomization

Participating in This Clinical Trial

Inclusion Criteria

1. COPD GOLD Stage 2 and 3 (post-bronchodilator FEV1 35-80% predicted and FEV1/FVC <0.7 at the time of enrollment in COPDGene) by spirometry.

2. Less than 15% of the lung <-950 Hounsfield Units on COPDGene high-resolution inspiratoryChest CT scan (i.e. no evidence of significant emphysema)

3. Greater than 10% gas trapping on COPDGene expiratory CT scan (i.e. evidence of small airway disease).

4. No history of recent use (within the pat 8 weeks) of an inhaled or systemic corticosteroid.

5. Body weight <100 kg (low dose CT scans in subject with increased boyd weight can not be reliably analyzed).

Exclusion Criteria

1. Exacerbation of COPD or other respiratory illness requiring antibiotics within the past 8 weeks.

2. Previous adverse reaction to inhaled steroids, long-acting beta agonists, or long-acting anticholinergic medications.

3. Symptomatic, untreated benign prostate hypertrophy.

4. Allergy to peanuts.

5. Glaucoma

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Jewish Health
  • Collaborator
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jennifer Brandorff, Manager, Clinical Research Services, Regulatory – National Jewish Health
  • Overall Official(s)
    • James D Crapo, MD, Principal Investigator, National Jewish Health
    • Edwin K Silverman, MD, PhD, Principal Investigator, Brigham and Women’s Hospital
    • Barry J Make, MD, Principal Investigator, National Jewish Health

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