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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00461812
• Collaborator: Schering-Plough (Industry)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Mometasone; Drug: Advair	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Jan 19, 2010
• Actual Study Completion Date: Jan 19, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mometasone	Drug: Mometasone
Experimental: Advair	Drug: Advair

Outcome Measures

Primary Outcome Measures

1. Efficacy as Assessed my Pulmonary Function Tests [change from baseline to study completion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Asthma and Allergy Center	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University
• Schering-Plough

Investigators

• Principal Investigator: Peter S Creticos, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00461812
• Other Study ID Numbers: NA_00001154
• First Posted: Apr 18, 2007
• Last Update Posted: Sep 20, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Asthma; Mometasone Furoate

Study Results

Participant Flow

Pre-assignment Detail	33 participants were consented for this study. However, there were 23 pre-randomization screening failures. Only 10 were enrolled. The number of participants assigned/randomized to each Arm/Group is unknown.

Arm/Group Title	All Participants
Arm/Group Description	Mometasone or Advair
Period Title: Overall Study
STARTED	10
COMPLETED	0
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Mometasone or Advair
Overall Participants	10
Age, Customized (Count of Participants)
>=18, <=16 years	10 100%
Sex: Female, Male (Count of Participants)
Female	6 60%
Male	4 40%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Efficacy as Assessed my Pulmonary Function Tests
Time Frame	change from baseline to study completion

Outcome Measure Data

Analysis Population Description

There is no data available for this outcome measure. The study was prematurely terminated and the PI is no longer with the institution. The information available was obtained from the IRB.

Arm/Group Title	Mometasone	Advair
Arm/Group Description	Mometasone	Advair
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	There is no data available for adverse events. The study was prematurely terminated and the PI is no longer with the institution. The information available was obtained from the IRB.
Arm/Group Title	All Participants
Arm/Group Description	Mometasone or Advair Adverse event data and the number of participants assigned to each Arm/Group is unknown because the PI left the institution and this information is unavailable
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.