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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Budesonide
budesonide/formoterol
Ipratropium/albuterol
Sponsored by
National Jewish Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama Birmingham Medical Center
  • Harbor UCLA Medical Center
  • National Jewish Health
  • University of Iowa
  • Brigham and Women's Hospital
  • Reliant Medical Group
  • Temple University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

ipratropium/albuterol

Budesonide

budesonide/formoterol

Arm Description

1 puff 4 times daily

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

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

Outcomes

Primary Outcome Measures

Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
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
Administer St. George's Respiratory Questionnaire at randomization and 12 weeks.
Dyspnea
Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.
Six minute walk distance
Evaluate six minute walk distance at randomization and 12 weeks
Forced vital capacity (FVC) pre-bronchodilator
Post-bronchodilator FEV1
Patient-reported exacerbations
Patient reported adverse events
Post-bronchodilator FVC
CT scan gas trapping

Full Information

First Posted
November 16, 2010
Last Updated
January 15, 2021
Sponsor
National Jewish Health
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01253473
Brief Title
Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)
Acronym
SACOPD
Official Title
COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ipratropium/albuterol
Arm Type
Active Comparator
Arm Description
1 puff 4 times daily
Arm Title
Budesonide
Arm Type
Experimental
Arm Description
budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
Arm Title
budesonide/formoterol
Arm Type
Experimental
Arm Description
budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Pulmicort Flexhaler®
Intervention Description
Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol
Other Intervention Name(s)
Symbicort®
Intervention Description
Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily
Intervention Type
Drug
Intervention Name(s)
Ipratropium/albuterol
Other Intervention Name(s)
Combivent®
Intervention Description
Inhaled ipratropium/albuterol combination 2 puffs four times daily
Primary Outcome Measure Information:
Title
Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Health Status
Description
Administer St. George's Respiratory Questionnaire at randomization and 12 weeks.
Time Frame
12 weeks
Title
Dyspnea
Description
Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.
Time Frame
12 weeks
Title
Six minute walk distance
Description
Evaluate six minute walk distance at randomization and 12 weeks
Time Frame
12 weeks
Title
Forced vital capacity (FVC) pre-bronchodilator
Time Frame
12 weeks
Title
Post-bronchodilator FEV1
Time Frame
12 weeks
Title
Patient-reported exacerbations
Time Frame
12 weeks
Title
Patient reported adverse events
Time Frame
12 weeks
Title
Post-bronchodilator FVC
Time Frame
12 weeks
Title
CT scan gas trapping
Time Frame
Before and 12 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Less than 15% of the lung <-950 Hounsfield Units on COPDGene high-resolution inspiratoryChest CT scan (i.e. no evidence of significant emphysema) Greater than 10% gas trapping on COPDGene expiratory CT scan (i.e. evidence of small airway disease). No history of recent use (within the pat 8 weeks) of an inhaled or systemic corticosteroid. Body weight <100 kg (low dose CT scans in subject with increased boyd weight can not be reliably analyzed). Exclusion Criteria: Exacerbation of COPD or other respiratory illness requiring antibiotics within the past 8 weeks. Previous adverse reaction to inhaled steroids, long-acting beta agonists, or long-acting anticholinergic medications. Symptomatic, untreated benign prostate hypertrophy. Allergy to peanuts. Glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Crapo, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edwin K Silverman, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barry J Make, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Reliant Medical Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Temple University Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

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