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An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma.

NCT01686633 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2018-01-24

Study results available
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Summary

This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).

Conditions

Interventions

DRUG

Fluticasone Furoate/ Vilanterol 200/25 mcg

Fluticasone furoate/ vilanterol will be available as 200/25 mcg Novel dry powder inhaler (NDPI) with 30 doses per device and 200/25 mcg per actuation

DRUG

Fluticasone Furoate/ Vilanterol 100/25 mcg

Fluticasone furoate/ vilanterol will be available as 100/25 mcg NDPI with 30 doses per device and 100/25 mcg per actuation

DRUG

Fluticasone Furoate 100 mcg

Fluticasone furoate will be available as 100 mcg NDPI with 30 doses per device and 100/25 mcg per actuation

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-20
Primary Completion
2013-10-01
Completion
2013-10-15

Countries

  • United States
  • Argentina
  • Chile
  • Germany
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Sweden
  • 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 NCT01686633 on ClinicalTrials.gov