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

Sponsor
National Jewish Health (Other)
Overall Status
Completed
CT.gov ID
NCT01253473
Collaborator
AstraZeneca (Industry)
46
Enrollment
7
Locations
3
Arms
45
Actual Duration (Months)
6.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
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
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 :
Apr 1, 2012
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Jan 1, 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 Names:
  • 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 Names:
  • Pulmicort Flexhaler®

    • Drug: Ipratropium/albuterol
    Inhaled ipratropium/albuterol combination 2 puffs four times daily
    Other Names:
  • 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 Names:
  • Symbicort®

    • Drug: Ipratropium/albuterol
    Inhaled ipratropium/albuterol combination 2 puffs four times daily
    Other Names:
  • Combivent®

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Administer St. George's Respiratory Questionnaire at randomization and 12 weeks.

    2. Dyspnea [12 weeks]

      Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.

    3. Six minute walk distance [12 weeks]

      Evaluate six minute walk distance at randomization and 12 weeks

    4. Forced vital capacity (FVC) pre-bronchodilator [12 weeks]

    5. Post-bronchodilator FEV1 [12 weeks]

    6. Patient-reported exacerbations [12 weeks]

    7. Patient reported adverse events [12 weeks]

    8. Post-bronchodilator FVC [12 weeks]

    9. CT scan gas trapping [Before and 12 weeks after randomization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Medical Center Birmingham Alabama United States 35294
    2 Harbor UCLA Medical Center Torrance California United States 90502
    3 National Jewish Health Denver Colorado United States 80206
    4 University of Iowa Iowa City Iowa United States 52242
    5 Brigham and Women's Hospital Boston Massachusetts United States 02115
    6 Reliant Medical Group Worcester Massachusetts United States 01608
    7 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Jewish Health
    ClinicalTrials.gov Identifier:
    NCT01253473
    Other Study ID Numbers:
    • SYMB0012
    First Posted:
    Dec 3, 2010
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by National Jewish Health
    COPD
    Additional relevant MeSH terms:
    Lung Diseases
    Pulmonary Disease, Chronic Obstructive
    Budesonide
    Albuterol
    Formoterol Fumarate
    Ipratropium

    Study Results

    No Results Posted as of Jan 19, 2021