A Dose-ranging Study of Fluticasone Furoate (FF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563029
First received: March 15, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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
Asthma
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


Estimated Enrollment: 575
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated 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
placebo

  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 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 ClinicalTrials.gov identifier: NCT01563029

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563029     History of Changes
Other Study ID Numbers: 106855
Study First Received: March 15, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014