Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Dose-ranging Study of Fluticasone Furoate (FF)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: March 15, 2012
Last updated: January 22, 2015
Last verified: January 2015

This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy, parallel-group, placebo and active controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period during which time they will continue their current medications. Visit 2 will occur two weeks into the run-in period to allow a review of compliance with daily diary and run-in medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility criteria who remain uncontrolled despite baseline therapy will be stratified based on pre screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to the treatment phase of the study where they will receive one of five treatments for 12 weeks. Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of 115 randomized/evaluable subjects per treatment arm. Subjects will attend on-treatment visits at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up contact will be performed one week after completing study medication. All subjects must attempt spirometry measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine collection for urinary cortisol and creatinine excretion will be performed prior to randomization at Visit 2 and within 7 days prior to Visit 7. All subjects must perform PEF daily between visits 1 and 7. The primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) PM PEF from patient hand held electronic daily diary at Endpoint (Endpoint is defined as the mean over the last 7 days of treatment). Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, urinary cortisol, and vital signs.

Condition Intervention Phase
Drug: Fluticasone Furoate
Drug: Fluticasone Propionate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose-ranging Study of Fluticasone Furoate (FF) Inhalation Powder in Children Aged 5-11 Years With Asthma

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Peak Expiratory Flow (PEF) [ Time Frame: last 7 days of treatment ] [ Designated as safety issue: No ]
    mean change from baseline

Secondary Outcome Measures:
  • Forced Expiratory Volume in one second (FEV1) [ Time Frame: at the end of the 12 week treatment ] [ Designated as safety issue: No ]
    change from baseline

Enrollment: 597
Study Start Date: March 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Fluticasone Furoate 100mcg inhalation powder once daily in the evening ICS powder
Drug: Fluticasone Furoate
current asthma medicine
Active Comparator: Arm 2
Fluticasone Furoate 50mcg inhalation powder once daily in the evening ICS powder
Drug: Fluticasone Furoate
current asthma medicine
Active Comparator: Arm 3
Fluticasone Furoate 25mcg inhalation powder once daily in the evening ics powder
Drug: Fluticasone Furoate
current asthma medicine
Active Comparator: Arm 4
Fluticasone Propionate 100mcg inhalation powder twice daily ICS powder
Drug: Fluticasone Propionate
Fluticasone propionate
Placebo Comparator: Arm 5
Placebo inhalation powder once daily in the evening Placebo powder
Drug: Placebo


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

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 therapy of short acting beta-agonist (SABA) alone, LTM, or ICS (total daily dose <FP 200mcg or equivalent)Exclusion :

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 identifier: NCT01563029

  Show 139 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT01563029     History of Changes
Other Study ID Numbers: 106855
Study First Received: March 15, 2012
Last Updated: January 22, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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 processed this record on February 27, 2015