Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Budesonide+ ipratropium/albuterol (Drug); budesonide/formoterol plus ipratropium/albuterol (Drug); Ipratropium/albuterol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Jewish Health

Official(s) and/or principal investigator(s):
James D Crapo, MD, Principal Investigator, Affiliation: National Jewish Health
Edwin K Silverman, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Barry J Make, MD, Principal Investigator, Affiliation: National Jewish Health

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.

Official title: COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Forced expiratory volume in 1 second (FEV1) pre-bronchodilator

Secondary outcome:

Health Status

Dyspnea

Six minute walk distance

Forced vital capacity (FVC) pre-bronchodilator

Post-bronchodilator FEV1

BODE Score

Patient-reported exacerbations

Patient reported adverse events

Post-bronchodilator FVC

CT scan gas trapping

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Harbor UCLA Medical Center, Torrance, California 90502, United States; Recruiting
Richard Casaburi, MD, PhD, Phone: 310-222-8267, Email: casaburi@ucla.edu
Richard Casaburi, MD, PhD, Principal Investigator

National Jewish Health, Denver, Colorado 80206, United States; Recruiting
Russell Bowler, MD, Phone: 303-398-1720, Email: bowlerr@njhealth.org
Barry J Make, MD, Phone: 303-398-1720, Email: makeb@njhealth.org
Russell Bowler, MD, PhD, Principal Investigator

University of Iowa, Iowa City, Iowa 52242, United States; Recruiting
Dwight Look, MD, Phone: 319-356-3603, Email: dwight-look@uiowa.edu
Dwight Look, MD, Principal Investigator

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Craig Hersh, MD, Phone: 617-525-0729, Email: craig.hersh@channing.harvard.edu
Craig Hersh, MD, Principal Investigator

Temple University Medical Center, Philadelphia, Pennsylvania 19140, United States; Recruiting
Gerard Criner, MD, Phone: 215-707-8113, Email: crinerg@tuhs.temple.edu
Gerard Criner, MD, Principal Investigator

Starting date: April 2012
Last updated: April 26, 2012