Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

NCT01253473 | Completed Phase 4 DMC

• 1 other identifier: SYMB0012
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 7

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (9)

• Health Status

  12 weeks

• Dyspnea

  12 weeks

• Six minute walk distance

  12 weeks

• Forced vital capacity (FVC) pre-bronchodilator

  12 weeks

• Post-bronchodilator FEV1

  12 weeks

Study Arms (3)

ipratropium/albuterol

ACTIVE COMPARATOR

1 puff 4 times daily

Drug: Ipratropium/albuterol

Budesonide

EXPERIMENTAL

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

Drug: Budesonide; Drug: Ipratropium/albuterol

budesonide/formoterol

EXPERIMENTAL

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

Drug: budesonide/formoterol; Drug: Ipratropium/albuterol

Interventions

Budesonide DRUG

Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed

Also known as: Pulmicort Flexhaler®

Budesonide

budesonide/formoterol DRUG

Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily

Also known as: Symbicort®

budesonide/formoterol

Ipratropium/albuterol DRUG

Inhaled ipratropium/albuterol combination 2 puffs four times daily

Also known as: Combivent®

Budesonide; budesonide/formoterol; ipratropium/albuterol

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Jewish Health: lead
• AstraZeneca: collaborator

Study Sites (7)

University of Alabama Birmingham Medical Center

Birmingham, Alabama, 35294, United States

Location

Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Reliant Medical Group

Worcester, Massachusetts, 01608, United States

Location

Temple University Medical Center

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Albuterol, Ipratropium Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations; Albuterol; Phenethylamines; Ethylamines; Ipratropium; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: December 3, 2010
• Study Start: April 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)