Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)
Information source: National Jewish Health
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: Budesonide+ ipratropium/albuterol (Drug); budesonide/formoterol plus ipratropium/albuterol (Drug); Ipratropium/albuterol (Drug)
Phase: Phase 4
Sponsored by: National Jewish Health
Official(s) and/or principal investigator(s):
James D Crapo, MD, Principal Investigator, Affiliation: National Jewish Health
Edwin K Silverman, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Barry J Make, MD, Principal Investigator, Affiliation: National Jewish Health
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.
Official title: COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
Six minute walk distance
Forced vital capacity (FVC) pre-bronchodilator
Patient reported adverse events
CT scan gas trapping
Minimum age: 45 Years.
Maximum age: 80 Years.
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
4. No history of recent use (within the pat 8 weeks) of an inhaled or systemic
5. Body weight <100 kg (low dose CT scans in subject with increased boyd weight can not
be reliably analyzed).
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.
Locations and Contacts
Harbor UCLA Medical Center, Torrance, California 90502, United States; Recruiting
Richard Casaburi, MD, PhD, Phone: 310-222-8267, Email: email@example.com
Richard Casaburi, MD, PhD, Principal Investigator
National Jewish Health, Denver, Colorado 80206, United States; Recruiting
Russell Bowler, MD, Phone: 303-398-1720, Email: firstname.lastname@example.org
Barry J Make, MD, Phone: 303-398-1720, Email: email@example.com
Russell Bowler, MD, PhD, Principal Investigator
University of Iowa, Iowa City, Iowa 52242, United States; Recruiting
Dwight Look, MD, Phone: 319-356-3603, Email: firstname.lastname@example.org
Dwight Look, MD, Principal Investigator
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Craig Hersh, MD, Phone: 617-525-0729, Email: email@example.com
Craig Hersh, MD, Principal Investigator
Temple University Medical Center, Philadelphia, Pennsylvania 19140, United States; Recruiting
Gerard Criner, MD, Phone: 215-707-8113, Email: firstname.lastname@example.org
Gerard Criner, MD, Principal Investigator
Starting date: April 2012
Last updated: April 26, 2012