Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

— SACOPD  

Official title:

COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253473
• Other study ID #: SYMB0012
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2021
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Budesonide
Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed
• budesonide/formoterol
Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily
• Ipratropium/albuterol
Inhaled ipratropium/albuterol combination 2 puffs four times daily

Locations

Country	Name	City	State
United States	University of Alabama Birmingham Medical Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	National Jewish Health	Denver	Colorado
United States	University of Iowa	Iowa City	Iowa
United States	Temple University Medical Center	Philadelphia	Pennsylvania
United States	Harbor UCLA Medical Center	Torrance	California
United States	Reliant Medical Group	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in 1 second (FEV1) pre-bronchodilator	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	12 weeks
Secondary	Health Status	Administer St. George's Respiratory Questionnaire at randomization and 12 weeks.	12 weeks
Secondary	Dyspnea	Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.	12 weeks
Secondary	Six minute walk distance	Evaluate six minute walk distance at randomization and 12 weeks	12 weeks
Secondary	Forced vital capacity (FVC) pre-bronchodilator		12 weeks
Secondary	Post-bronchodilator FEV1		12 weeks
Secondary	Patient-reported exacerbations		12 weeks
Secondary	Patient reported adverse events		12 weeks
Secondary	Post-bronchodilator FVC		12 weeks
Secondary	CT scan gas trapping		Before and 12 weeks after randomization