A dose-ranging study of fluticasone furoate (FF) inhalation powder in children aged 5-11 years with asthma
- Conditions
- Chronic disease of the lungs characterized by airway inflammation,bonchoconstriction and increased airway responsiveness.MedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2011-003338-15-PL
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 575
1. Informed Consent: Written informed consent from at least one parent/care giver and accompanying informed assent from the subject (where the subject is able to provide assent) prior to admission to the study.
• If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement. The study investigator is accountable for determining a child's capacity to assent to participation in a research study, taking into consideration any standards set by the responsible IEC/IRB.
• Subject and their legal guardian understand that the study requires them to be treated on an outpatient basis.
• Subject and their legal guardian understand that they must comply with study medication and study assessments including recording of symptom scores and rescue albuterol/salbutamol use, attending scheduled study visits, and being accessible by a telephone call.
2. Age: 5-11 years at visit 1.
3. Gender: Male and pre-menarchial female. Pre-menarchial females are defined as any female who has yet to begin menses.
4. Diagnosis of asthma: Subjects must have a history of symptoms consistent with a diagnosis of asthma for at least 6 months prior to Visit 1.
5. Reversibility component for subjects able to perform acceptable pre and post bronchodilator FEV1 during the screening visit: Subjects must demonstrate lung function reversibility with an increase of =12% in FEV1 within 10-40 minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent
nebulized treatment with albuterol/salbutamol solution). Subjects unable to perform acceptable pre and post bronchodilator FEV1 can still be enrolled provided they meet all other subject selection criteria.
6. Asthma Severity: Subjects must have a pre-bronchodilator PEF of between =60% to =90% of their best post-bronchodilator value (calculated from Visit 1 reversibility testing using spirometry generated PEF values).
7. Current asthma therapy: Subjects must be using one of the following three stable asthma therapies for at least 4 weeks prior to screening: a. Short acting beta-agonist (SABA) inhaler alone without controller therapy (e.g. leukotriene modifying agent, ICS);or
b. Short acting beta-agonist (SABA) inhaler with leukotriene modifying agent mono therapy; or c. Short acting beta-agonist (SABA) inhaler with low-dose ICS mono therapy (total daily dose = FP 250mcg or equivalent).See table for dose equivalents in protocol P19
8.Ability to use Dry Powder Inhalers: Subjects must demonstrate the ability to use the Novel Dry Powder Inhaler (NDPI) and the DISKUS/ACCUHALER under the supervision of their parents/carers.
9. Short-Acting Beta2-Agonists (SABA): All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits. Albuterol/salbutamol
MDI will be administered with or without a spacer to be used as determined by the investigator. The use or non-use of the spacer should be consistent for an individual subject throughout the study.
10. Peak Flow Meter/Daily Diary: A subject must be able to use the study-provided peak flow meter and the subject/caregiver must be able to maintain the electronic diary record.
Are the trial subjects under 18? yes
Number of subjects for this age range: 575
F.1.2 Adults (18-64 years) no
F.1.2.1 Numbe
1. Life Threatening Asthma: Subjects with a history of life-threatening asthma defined for this protocol as an asthma episode that required intubation, hypercapnea requiring non-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode(s).
2. Asthma Exacerbation: Subjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a depot corticosteroid injection (within 3 months) or requiring hospitalization for asthma (within 6 months) prior to screening.
3. Concomitant medications: Subjects currently receiving (or have received within 4 weeks of screening) asthma therapies including theophyllines, long-acting inhaled beta-agonists, oral beta-agonists, or who have changed their asthma medication within 4 weeks of screening. Concomitant Medication: Use of the following
medications is prohibited according to the timeframes below: FOR TABLE PLEASE REFER TO PROTOCOL P20
4. Infections: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject’s asthma status or the subject’s ability to participate in the study.
5. Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of candidiasis at Visit 1.
6. Concurrent Diseases/ Abnormalities: Any significant abnormality or medical condition identified at the screening medical assessment (including serious psychological disorder) likely to interfere with the conduct of the study.
7. Allergies:
Drug allergies: Any adverse reaction including immediate or delayed
hypersensitivity to any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose).
Milk Protein Allergy: History of severe milk protein allergy.
8. Tobacco use: Present use of any tobacco products
9. Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
10. Previous Exposure to Investigational Product: Subjects who have previously been exposed to FF including in clinical studies HZA102942 or HZA112777.
11. Parental/ Guardian Factors: Parent or Guardian with a history of psychiatric disease, intellectual deficiency, substance abuse or other condition (e.g. inability to read, comprehend or write) which may affect:• validity of consent to participate in the study
• adequate supervison of the subject during the study
• compliance of subject with study medication and study procedures
(e.g.completion of daily diary, attending scheduled clinic visits)
• subject safety and well-being
12. Children in Care: Children who are wards of the government or state are not eligible for participation in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the dose response, efficacy and safety of three doses of FF inhalation powder administered once daily in the evening to children aged 5-11 years with persistent uncontrolled asthma over a 12 week treatment period.;Secondary Objective: To characterise the population pharmacokinetics of fluticasone furoate in subjects with persistent asthma.;Primary end point(s): The primary endpoint will be the mean change from baseline in daily<br>pre-dose AM PEF from patient electronic daily diary averaged over the 12<br>week treatment period.<br>;Timepoint(s) of evaluation of this end point: Average of daily pre-dose AM PEF over the 12 week treatment period
- Secondary Outcome Measures
Name Time Method