Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Jewish Health
• Collaborator: AstraZeneca
• Treatments: Albuterol; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate; Ipratropium

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