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Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

NCT01253473 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-01-19

No results posted yet for this study

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

Interventions

DRUG

Budesonide

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

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

DRUG

Ipratropium/albuterol

Inhaled ipratropium/albuterol combination 2 puffs four times daily

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • National Jewish Health

    lead OTHER

Principal Investigators

  • James D Crapo, MD · National Jewish Health

  • Edwin K Silverman, MD, PhD · Brigham and Women's Hospital

  • Barry J Make, MD · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-09-30
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01253473 on ClinicalTrials.gov