Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD) (SACOPD)

National Jewish Health

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: budesonide/formoterol; Drug: Budesonide; Drug: Ipratropium/albuterol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01253473

SYMB0012

Details and patient eligibility

About

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.

Full 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

Enrollment: 46 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 3 patient groups

ipratropium/albuterol

Active Comparator group

Description:

1 puff 4 times daily

Treatment:

Drug: Ipratropium/albuterol

Budesonide

Experimental group

Description:

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

Treatment:

Drug: Ipratropium/albuterol

Drug: Budesonide

budesonide/formoterol

Experimental group

Description:

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

Treatment:

Drug: Ipratropium/albuterol

Drug: budesonide/formoterol