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Asthma Exacerbation Study

NCT01086384 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2020

Last updated 2018-01-24

Study results available
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Summary

This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.

Conditions

Interventions

DRUG

Fluticasone Furoate/GW642444

Combination inhaled corticosteroid and long-acting beta2-agonist

DRUG

Fluticasone furoate

Inhaled corticosteroid

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-22
Primary Completion
2011-09-01
Completion
2011-09-15

Countries

  • United States
  • Argentina
  • Australia
  • Germany
  • Japan
  • Mexico
  • Philippines
  • Poland
  • Romania
  • Russia
  • Ukraine

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 NCT01086384 on ClinicalTrials.gov