Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
COPD
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
Interventions
DRUGBudesonide
Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed
DRUGbudesonide/formoterol
Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily
DRUGIpratropium/albuterol
Inhaled ipratropium/albuterol combination 2 puffs four times daily
Sponsors
AstraZeneca
National Jewish Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Six minute walk distance | 12 weeks | Evaluate six minute walk distance at randomization and 12 weeks |
| Forced vital capacity (FVC) pre-bronchodilator | 12 weeks | — |
| Post-bronchodilator FEV1 | 12 weeks | — |
| Patient-reported exacerbations | 12 weeks | — |
| Patient reported adverse events | 12 weeks | — |
| Post-bronchodilator FVC | 12 weeks | — |
| CT scan gas trapping | Before and 12 weeks after randomization | — |
Countries
United States
Outcome results
None listed