NCT00238082

Brief Summary

This is an investigator-sponsored research study to evaluate if treatment with HFA-134a beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway "remodeling" or scarring in subjects with COPD. Approximately 20 subjects with COPD will participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with HFA-134a and 10 receiving a placebo.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

5.3 years

First QC Date

October 11, 2005

Last Update Submit

March 27, 2017

Conditions

COPD

Keywords

COPDChronic Obstructive Pulmonary DiseaseEmphysemaChronic Bronchitis

Outcome Measures

Primary Outcomes (2)

  • Spirometric response (FEV1)

  • Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio

Interventions

HFA-134A Beclomethasone DIpropionate (QVAR)DRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD diagnosis
  • FEV1/FVC\<70%
  • FEV1 50-80% predicted
  • Albuterol response of \<12% and \<200mL or methacholine PC20 \> 8mg/mL
  • RV \> 120% predicted
  • DLCO \< 80%
  • smokers and nonsmokers
  • Lower age limit 45 years

You may not qualify if:

  • Asthma
  • Other chronic airway or parenchymal lung disease
  • Other comorbid illness (including but not limited to DM, MI or CAD-related intervention in 6 months, neurologic disease, syncope)
  • Use of any steroid (oral, IV, nasal, pulmonary) within 12 weeks
  • Use of theophylline, leukotriene modifiers within 12 weeks
  • Use of long-acting beta-agonists (formoterol, salmeterol) or anticholinergic (tiotropium)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaBronchitis, Chronic

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • Richard Martin, MD

    National Jewish Medical and Research Center faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 13, 2005

Study Start

November 1, 1999

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

US(1)