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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Jewish Health
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Barry Make, National Jewish Health
ClinicalTrials.gov Identifier:
NCT01253473
First received: November 16, 2010
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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: Open Label
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Administer St. George's Respiratory Questionnaire at randomization and 12 weeks.

  • Dyspnea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.

  • Six minute walk distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate six minute walk distance at randomization and 12 weeks

  • Forced vital capacity (FVC) pre-bronchodilator [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Post-bronchodilator FEV1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • BODE Score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Calculation of body mass index, airflow obstruction (post-bronchodilator FEV1), dyspnea (assessed from MMRC score) and exercise capacity (assessed by six-minute walk evaluation)

  • Patient-reported exacerbations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient reported adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Post-bronchodilator FVC [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • CT scan gas trapping [ Time Frame: Before and 12 weeks after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 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

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01253473

Locations
United States, Alabama
University of Alabama Birmingham Medical Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Mark Dransfield, MD    205-934-5425    mdransfield99@msn.com   
United States, California
Harbor UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Richard Casaburi, MD, PhD    310-222-8267    casaburi@ucla.edu   
Principal Investigator: Richard Casaburi, MD, PhD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Russell Bowler, MD    303-398-1720    bowlerr@njhealth.org   
Contact: Barry J Make, MD    303-398-1720    makeb@njhealth.org   
Principal Investigator: Russell Bowler, MD, PhD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Alejandro Comellas, MD    319-384-6484    dwight-look@uiowa.edu   
Principal Investigator: Alejandro Comellas, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Craig Hersh, MD    617-525-0729    craig.hersh@channing.harvard.edu   
Principal Investigator: Craig Hersh, MD         
Reliant Medical Group Recruiting
Worcester, Massachusetts, United States, 01608
Contact: Richard Rosiello, MD    508-368-3120    richard.rosiello@reliantmedicalgroup.org   
United States, Pennsylvania
Temple University Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Gerard Criner, MD    215-707-8113    crinerg@tuhs.temple.edu   
Principal Investigator: Gerard Criner, MD         
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

No publications provided

Responsible Party: Barry Make, Co-Director, COPD Program, National Jewish Health
ClinicalTrials.gov Identifier: NCT01253473     History of Changes
Other Study ID Numbers: SYMB0012
Study First Received: November 16, 2010
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
COPD

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Albuterol
Budesonide
Formoterol
Ipratropium
Symbicort
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014