Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT01253473
- Lead Sponsor
- National Jewish Health
- 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 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ipratropium/albuterol Ipratropium/albuterol 1 puff 4 times daily Budesonide Ipratropium/albuterol budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily Budesonide Budesonide budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily budesonide/formoterol budesonide/formoterol budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily budesonide/formoterol Ipratropium/albuterol budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
- Primary Outcome Measures
Name Time Method Forced expiratory volume in 1 second (FEV1) pre-bronchodilator 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 Outcome Measures
Name Time Method Patient-reported exacerbations 12 weeks Health Status 12 weeks Administer St. George's Respiratory Questionnaire at randomization and 12 weeks.
Dyspnea 12 weeks Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.
CT scan gas trapping Before and 12 weeks after randomization Post-bronchodilator FEV1 12 weeks Patient reported adverse events 12 weeks Forced vital capacity (FVC) pre-bronchodilator 12 weeks Six minute walk distance 12 weeks Evaluate six minute walk distance at randomization and 12 weeks
Post-bronchodilator FVC 12 weeks
Trial Locations
- Locations (7)
Reliant Medical Group
🇺🇸Worcester, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Alabama Birmingham Medical Center
🇺🇸Birmingham, Alabama, United States
Harbor UCLA Medical Center
🇺🇸Torrance, California, United States
Temple University Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States