A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma

Asthma Clinical Trial

Official title:

A Single-Blind, Randomized, Positive-controlled Study to Compare Monotherapy With an Inhaled Corticosteroid (Mometasone) to Combination Therapy With an Inhaled Corticosteroid + a Long-Acting Bronchodilator (Advair) in Patients With Milder Persistent Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00461812
• Other study ID #: NA_00001154
• Status: Terminated
• Phase: Phase 4
• First received: April 16, 2007
• Last updated: September 19, 2017
• Start date: April 2007
• Est. completion date: January 19, 2010

Study information

• Verified date: September 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma?

The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: January 19, 2010
• Est. primary completion date: January 19, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• subjects 18 to 65 years of age

• a >2 year history of asthma

• FEV1 > 80% for subjects currently using Advair®.

Exclusion Criteria:

• severe asthma

• current smokers

• pregnant or breast-feeding women

• other chronic significant illnesses

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Mometasone

• Advair

Locations

Country	Name	City	State
United States	Johns Hopkins Asthma and Allergy Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as Assessed my Pulmonary Function Tests		change from baseline to study completion