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

• ClinicalTrials.gov Identifier: NCT01253473
• Recruitment Status: Completed
• First Posted: December 3, 2010
• Last Update Posted: January 19, 2021
• Sponsor: National Jewish Health
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): National Jewish Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Budesonide; Drug: budesonide/formoterol; Drug: Ipratropium/albuterol	Phase 4

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant
• Actual Study Start Date: April 2012
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ipratropium/albuterol; 1 puff 4 times daily	Drug: Ipratropium/albuterol; Inhaled ipratropium/albuterol combination 2 puffs four times daily; Other Name: Combivent®
Experimental: Budesonide; budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily	Drug: Budesonide; Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed; Other Name: Pulmicort Flexhaler®; Drug: Ipratropium/albuterol; Inhaled ipratropium/albuterol combination 2 puffs four times daily; Other Name: Combivent®
Experimental: budesonide/formoterol; budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily	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; Other Name: Symbicort®; Drug: Ipratropium/albuterol; Inhaled ipratropium/albuterol combination 2 puffs four times daily; Other Name: Combivent®

Outcome Measures

Primary Outcome Measures :

1. Forced expiratory volume in 1 second (FEV1) pre-bronchodilator [ Time Frame: 12 weeks ]
   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

Secondary Outcome Measures :

1. Health Status [ Time Frame: 12 weeks ]
   Administer St. George's Respiratory Questionnaire at randomization and 12 weeks.
2. Dyspnea [ Time Frame: 12 weeks ]
   Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.
3. Six minute walk distance [ Time Frame: 12 weeks ]
   Evaluate six minute walk distance at randomization and 12 weeks
4. Forced vital capacity (FVC) pre-bronchodilator [ Time Frame: 12 weeks ]
5. Post-bronchodilator FEV1 [ Time Frame: 12 weeks ]
6. Patient-reported exacerbations [ Time Frame: 12 weeks ]
7. Patient reported adverse events [ Time Frame: 12 weeks ]
8. Post-bronchodilator FVC [ Time Frame: 12 weeks ]
9. CT scan gas trapping [ Time Frame: Before and 12 weeks after randomization ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama Birmingham Medical Center

Birmingham, Alabama, United States, 35294

United States, California

Harbor UCLA Medical Center

Torrance, California, United States, 90502

United States, Colorado

National Jewish Health

Denver, Colorado, United States, 80206

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Reliant Medical Group

Worcester, Massachusetts, United States, 01608

United States, Pennsylvania

Temple University Medical Center

Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

National Jewish Health

AstraZeneca

Investigators

• Principal Investigator: James D Crapo, MD; National Jewish Health
• Principal Investigator: Edwin K Silverman, MD, PhD; Brigham and Women's Hospital
• Principal Investigator: Barry J Make, MD; National Jewish Health

More Information

• Responsible Party: National Jewish Health
• ClinicalTrials.gov Identifier: NCT01253473
• Other Study ID Numbers: SYMB0012
• First Posted: December 3, 2010
• Last Update Posted: January 19, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by National Jewish Health:

COPD

Additional relevant MeSH terms:

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Lung Diseases, Obstructive; Budesonide; Albuterol; Formoterol Fumarate; Ipratropium; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Tocolytic Agents; Reproductive Control Agents; Cholinergic Antagonists