A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

May 31, 2015

Study Completion Date

November 30, 2016

Conditions
Asthma
Interventions
DRUG

Fluticasone 250 mg/salmeterol 50 mg

Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo

DRUG

Montelukast 10mg

Participants will be assigned to montelukast once a day for 24 weeks.

DRUG

Theophylline 400 mg

Participants will be assigned to theophylline once a day for 24 weeks

DRUG

ipratropium

Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.

Trial Locations (1)

92103

Airway Research & Clinical Trials Center, San Diego

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of California, San Diego

OTHER

NCT01696214 - A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial | Biotech Hunter | Biotech Hunter