Status:
COMPLETED
Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
National Jewish Health
Collaborating Sponsors:
AstraZeneca
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
Brief 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 trea...
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 adminis...
Eligibility Criteria
Inclusion
- 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.
- Less than 15% of the lung \<-950 Hounsfield Units on COPDGene high-resolution inspiratoryChest CT scan (i.e. no evidence of significant emphysema)
- Greater than 10% gas trapping on COPDGene expiratory CT scan (i.e. evidence of small airway disease).
- No history of recent use (within the pat 8 weeks) of an inhaled or systemic corticosteroid.
- Body weight \<100 kg (low dose CT scans in subject with increased boyd weight can not be reliably analyzed).
Exclusion
- Exacerbation of COPD or other respiratory illness requiring antibiotics within the past 8 weeks.
- Previous adverse reaction to inhaled steroids, long-acting beta agonists, or long-acting anticholinergic medications.
- Symptomatic, untreated benign prostate hypertrophy.
- Allergy to peanuts.
- Glaucoma
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01253473
Start Date
April 1 2012
End Date
January 1 2016
Last Update
January 19 2021
Active Locations (7)
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1
University of Alabama Birmingham Medical Center
Birmingham, Alabama, United States, 35294
2
Harbor UCLA Medical Center
Torrance, California, United States, 90502
3
National Jewish Health
Denver, Colorado, United States, 80206
4
University of Iowa
Iowa City, Iowa, United States, 52242