Overview

This trial is active, not recruiting.

Condition pulmonary disease, chronic obstructive
Treatments budesonide, budesonide/formoterol, ipratropium/albuterol
Phase phase 4
Sponsor National Jewish Health
Collaborator AstraZeneca
Start date April 2012
End date September 2015
Trial size 46 participants
Trial identifier NCT01253473, SYMB0012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
1 puff 4 times daily
ipratropium/albuterol Combivent®
Inhaled ipratropium/albuterol combination 2 puffs four times daily
(Experimental)
budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
budesonide Pulmicort Flexhaler®
Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed
ipratropium/albuterol Combivent®
Inhaled ipratropium/albuterol combination 2 puffs four times daily
(Experimental)
budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
budesonide/formoterol Symbicort®
Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily
ipratropium/albuterol Combivent®
Inhaled ipratropium/albuterol combination 2 puffs four times daily

Primary Outcomes

Measure
Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
time frame: 12 weeks

Secondary Outcomes

Measure
Health Status
time frame: 12 weeks
Dyspnea
time frame: 12 weeks
Six minute walk distance
time frame: 12 weeks
Forced vital capacity (FVC) pre-bronchodilator
time frame: 12 weeks
Post-bronchodilator FEV1
time frame: 12 weeks
Patient-reported exacerbations
time frame: 12 weeks
Patient reported adverse events
time frame: 12 weeks
Post-bronchodilator FVC
time frame: 12 weeks
CT scan gas trapping
time frame: Before and 12 weeks after randomization

Eligibility Criteria

Male or female participants from 45 years up to 80 years old.

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

Additional Information

Official title COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant
Principal investigator James D Crapo, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by National Jewish Health.