Clinical trial NCT01253473: Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)
Official title: COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2010-12-03
Enrollment: 46
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
timeFrame: 12 weeks
Secondary outcomes:
measure: Health Status
timeFrame: 12 weeks
measure: Dyspnea
timeFrame: 12 weeks
measure: Six minute walk distance
timeFrame: 12 weeks
measure: Forced vital capacity (FVC) pre-bronchodilator
timeFrame: 12 weeks
measure: Post-bronchodilator FEV1
timeFrame: 12 weeks
measure: Patient-reported exacerbations
timeFrame: 12 weeks
measure: Patient reported adverse events
timeFrame: 12 weeks
measure: Post-bronchodilator FVC
timeFrame: 12 weeks
measure: CT scan gas trapping
timeFrame: Before and 12 weeks after randomization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham Medical Center
state: Alabama
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Reliant Medical Group
state: Massachusetts
city: Philadelphia
country: United States
facility: Temple University Medical Center
state: Pennsylvania
Study officials:
affiliation: National Jewish Health
name: James D Crapo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Edwin K Silverman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Jewish Health
name: Barry J Make, MD
role: PRINCIPAL_INVESTIGATOR
References: