The Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00238082
• Other study ID #: HS-1277
• Status: Terminated
• Phase: N/A
• First received: October 11, 2005
• Last updated: March 27, 2017
• Start date: November 1999
• Est. completion date: February 2005

Study information

• Verified date: March 2017
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• HFA-134A Beclomethasone DIpropionate (QVAR)

Locations

Country	Name	City	State
United States	National Jewish Medical and Research Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spirometric response (FEV1)
Primary	Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio

External Links

•   clinical lab website within National Jewish Medical and Research Center