Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ipratropium/albuterol

1 puff 4 times daily

Group Type ACTIVE_COMPARATOR

Ipratropium/albuterol

Intervention Type DRUG

Inhaled ipratropium/albuterol combination 2 puffs four times daily

Budesonide

budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed

Ipratropium/albuterol

Intervention Type DRUG

Inhaled ipratropium/albuterol combination 2 puffs four times daily

budesonide/formoterol

budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily

Group Type EXPERIMENTAL

budesonide/formoterol

Intervention Type DRUG

Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily

Ipratropium/albuterol

Intervention Type DRUG

Inhaled ipratropium/albuterol combination 2 puffs four times daily

Interventions

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Budesonide

Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed

Intervention Type DRUG

budesonide/formoterol

Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily

Intervention Type DRUG

Ipratropium/albuterol

Inhaled ipratropium/albuterol combination 2 puffs four times daily

Intervention Type DRUG

Other Intervention Names

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Pulmicort Flexhaler® Symbicort® Combivent®

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No