Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01573767
First received: March 8, 2012
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.


Condition Intervention Phase
Asthma
Drug: Fluticasone propionate 100mcg
Drug: Placebo
Drug: Vilanterol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children Aged 5-11 Years With Asthma on a Background of Inhaled Corticosteroid Therapy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PEF (peak Flow rate) [ Time Frame: baseline is the last 7 days prior to ramdomization Endpoint is defined as the mean over the last 7 days of 4 week treatment ] [ Designated as safety issue: No ]
    change from baseline in pre-dose (i.e. dosing trough) PM PEF from patient hand held electronic daily diary compared to endpoint


Secondary Outcome Measures:
  • FEV1 (Forced expiratory volume in one second) [ Time Frame: Change from baseline compared to the end of the 4 week treatment period ] [ Designated as safety issue: No ]
    Clinic visit (pre-bronchodilator and pre-dose) FEV1 in children who can perform the manoeuvre


Enrollment: 459
Study Start Date: April 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Vilanterol 25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
Drug: Fluticasone propionate 100mcg
all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
Drug: Vilanterol
subjects will recieve 4 weeks via NDPI during treament period
Active Comparator: Arm 2
Vilanterol 12.5mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
Drug: Fluticasone propionate 100mcg
all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
Drug: Vilanterol
subjects will recieve 4 weeks via NDPI during treament period
Active Comparator: Arm 3
Vilanterol 6.25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
Drug: Fluticasone propionate 100mcg
all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
Drug: Vilanterol
subjects will recieve 4 weeks via NDPI during treament period
Placebo Comparator: Arm 4
Placebo inhalation powder inhaled once daily in the PM via the new powder inhaler
Drug: Fluticasone propionate 100mcg
all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
Drug: Placebo
Placebo inhalation powder during treatment period

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent from at least one parent/ legal guardian to take part in the study.:
  • Diagnosis of asthma
  • pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
  • Receiving stable asthma therapy of short acting beta-agonist (SABA) plus ICS (total daily dose FP 200mcg or equivalent)

Exclusion Criteria:

  • history of life-threatening asthma
  • history of asthma exacerbation for asthma within 6 months prior to screening.
  • Culture-documented or suspected bacterial or viral infection
  • significant abnormality or medical condition
  • Present use of any tobacco products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573767

  Show 121 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01573767     History of Changes
Other Study ID Numbers: 106853
Study First Received: March 8, 2012
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014