Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)
Completed · Phase 4
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
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.
Key facts
- Study ID
- NCT01253473
- Run by
- National Jewish Health
- People needed
- 46
- Starts
- 2012-04-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2021-01-19
Who can join
Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- University of Alabama Birmingham Medical Center — Birmingham, Alabama, United States
- Harbor UCLA Medical Center — Torrance, California, United States
- National Jewish Health — Denver, Colorado, United States
- University of Iowa — Iowa City, Iowa, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Reliant Medical Group — Worcester, Massachusetts, United States
- Temple University Medical Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.