MedTrace Logo

Long-acting Beta Agonist Step Down Study

NCT01437995 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2017-04-25

Study results available
· View outcomes & findings →

Summary

This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group comparative effectiveness study of approaches to stepping down therapy for patients with well-controlled asthma treated with combination ICS and LABA.

Conditions

Interventions

DRUG

Fluticasone/Salmeterol Diskus

Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily

DRUG

Fluticasone/Salmeterol Diskus

Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily

DRUG

Fluticasone Diskus

Fluticasone Diskus alone 250 ug twice daily without Salmeterol

Sponsors & Collaborators

Principal Investigators

  • Robert A Wise, MD · Johns Hopkins University

  • Linda Rogers, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437995 on ClinicalTrials.gov