A Dose-ranging Study of Fluticasone Furoate (FF)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Fluticasone Furoate; Drug: Placebo; Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563029

106855

Details and patient eligibility

About

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.

Enrollment: 597 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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597 participants in 5 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

Fluticasone Furoate 100mcg inhalation powder once daily in the evening ICS powder

Treatment:

Drug: Fluticasone Furoate

Arm 2

Active Comparator group

Description:

Fluticasone Furoate 50mcg inhalation powder once daily in the evening ICS powder

Treatment:

Drug: Fluticasone Furoate

Arm 3

Active Comparator group

Description:

Fluticasone Furoate 25mcg inhalation powder once daily in the evening ics powder

Treatment:

Drug: Fluticasone Furoate

Arm 4

Active Comparator group

Description:

Fluticasone Propionate 100mcg inhalation powder twice daily ICS powder

Treatment:

Drug: Fluticasone Propionate

Arm 5

Placebo Comparator group

Description:

Placebo inhalation powder once daily in the evening Placebo powder

Treatment:

Drug: Placebo