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

This study has been completed.
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health Identifier:
First received: November 16, 2010
Last updated: March 27, 2017
Last verified: March 2017
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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Budesonide
Drug: budesonide/formoterol
Drug: Ipratropium/albuterol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant

Resource links provided by NLM:

Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • 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:
  • Health Status [ Time Frame: 12 weeks ]
    Administer St. George's Respiratory Questionnaire at randomization and 12 weeks.

  • Dyspnea [ Time Frame: 12 weeks ]
    Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.

  • Six minute walk distance [ Time Frame: 12 weeks ]
    Evaluate six minute walk distance at randomization and 12 weeks

  • Forced vital capacity (FVC) pre-bronchodilator [ Time Frame: 12 weeks ]
  • Post-bronchodilator FEV1 [ Time Frame: 12 weeks ]
  • Patient-reported exacerbations [ Time Frame: 12 weeks ]
  • Patient reported adverse events [ Time Frame: 12 weeks ]
  • Post-bronchodilator FVC [ Time Frame: 12 weeks ]
  • CT scan gas trapping [ Time Frame: Before and 12 weeks after randomization ]

Enrollment: 46
Actual Study Start Date: April 2012
Study Completion Date: January 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01253473

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
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: Jennifer Brandorff, Manager, Clinical Research Services, Regulatory, National Jewish Health Identifier: NCT01253473     History of Changes
Other Study ID Numbers: SYMB0012
Study First Received: November 16, 2010
Last Updated: March 27, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by National Jewish Health:

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017