Study of ADVAIR DISKUS and FLOVENT DISKUS taken twice daily in children during fall viral season.
- Conditions
- AsthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-004887-13-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 339
- Outpatient
- Subjects must be between the ages of 4 and 11 at Randomization
- Subjects must attend day-care, pre-school, elementary school, or middle school. Day-care attendance is defined as receiving childcare outside the home for at least 10 hours per week. Children who are home-schooled are not eligible for this study. Children on year round and traditional school calendars are eligible for this study.
- Subjects can be randomized into this study at any time between August 2nd, 2010 and August 20th, 2010.
- Males or pre-menarchal females.
- A diagnosis of asthma, as defined by the National Institutes of Health [NIH, 2007]
- At Visit 1 subjects must demonstrate a best clinic AM PEF =70% of the predicted value [Polgar, 1971].
- Each subject must have a history of an exacerbation of asthma between September 1st, 2009 and May 15th, 2010 that required a burst of outpatient systemic corticosteroids (oral or parenteral on >1 days for worsening symptoms of asthma) or have had an urgent care, hospitalization, or ED visit for asthma during which they received oral/parenteral corticosteroids between September 1st, 2009 and May 15th, 2010.
- Subjects must have prior or current use of controller ICS medication as listed below:
-Subjects who have had prior use of a controller medication consisting of a low dose ICS at any time since September 1st, 2009 are eligible for inclusion in this study (refer to Table 1 for examples of allowed doses of commonly used ICS).
-Subjects currently taking a low dose ICS are eligible for inclusion in the study (refer to Table 1 for examples of allowed doses of commonly used ICS).
-Subjects’ currently taking a moderate dose ICS are eligible for inclusion in the study if the subject’s asthma has been controlled over the prior 3 months and the subject is a candidate for step down therapy, as defined by current asthma management guidelines [NIH, 2007].
-Subjects’ currently taking low dose ICS in combination with a LABA are eligible for inclusion in the study if the subject’s asthma has been controlled over the prior 3 months and the subject is a candidate for step down therapy, as defined by current asthma management guidelines [NIH, 2007].
Are the trial subjects under 18? yes
Number of subjects for this age range: 339
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- History of Life Threatening Asthma
- Unstable Asthma
- Concomitant use of corticosteroid medication
- Other Concurrent Diseases/Abnormalities: The known presence of sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within 4 weeks immediately preceding randomization that required the use of an antibiotic or was accompanied by symptoms of worsening asthma.
- Concomitant Medications: Administration of any other prescription or over the counter medication which would significantly affect the course of asthma, such as omalizumab (Xolair), or interact with sympathomimetic amines, such as: anticonvulsants (barbiturates, hydantoins, carbamazepine), polycyclic antidepressants, beta-adrenergic blocking agents (both cardio-selective and non-selective), phenothiazines,
- Cytochrome P450 3A4 (CYP 3A4) Inhibitors: A subject is not eligible if he/she is receiving a strong CYP 3A4 inhibitor within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).
- Immunosuppressive medications: A subject must not be using or require use of immunosuppressive medications (e.g. methotrexate, gold, cyclosporine, azathioprine) during the study.
Note: Immunotherapy for the treatment of allergies is allowed during the study provided it was initiated 4 weeks prior to Visit 1 and the subject remains in the maintenance phase for the duration of the study.
- Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, cystic fibrosis, dyspnea by any cause other than asthma, or other respiratory abnormalities other than asthma.
- Other Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
The list of additional excluded conditions/diseases includes, but is not limited to the following:
Uncontrolled hypertension; Uncontrolled hematologic, hepatic, neurologic, or renal disease
Uncontrolled gastroesophageal reflux disease, Immunologic compromise, Cardiac arrhythmias, Tuberculosis (current or untreated), Congestive heart failure, Cushing’s disease
Coronary artery disease, Addison’s disease, Current malignancy, Eosinophilic esophagitis
Uncontrolled diabetes mellitus, Uncontrolled thyroid disorder
- Severe Hypersensitivity to Milk Proteins: Any immediate hypersensitivity reaction, such as urticaria, angioedema, rash, and bronchospasm to milk proteins
- Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the Dry Powder Inhaler (i.e., lactose).
- Tobacco Use: A history of or present use of any tobacco products.
- Investigational Medications: A subject must not have participated in a study (including a non-interventional study) or used any investigational drug (including devices) within 30 days prior to Visit 1 or within ten half-lives (t1/2) of the prior investigational study (whichever is longer of the two).
- Child in Care: A Child in Care (CiC) is a child who has been placed under the control or protection of an a
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 exploratory study was to assess whether treatment with FSC DISKUS 100/50 mcg twice-daily results in a clinically meaningful decrease in the risk of asthma exacerbations during the fall season when compared with the same dose of ICS in FP DISKUS 100 mcg twice daily.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint of this study was the number of exacerbations of asthma (defined above) during the double-blind treatment period. In addition, the time-adjusted relative risk of having an exacerbation was modeled.;Timepoint(s) of evaluation of this end point: 16 weeks
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 16 weeks;Secondary end point(s): Secondary efficacy endpoints included the severity and duration of asthma symptoms associated with moderate or severe upper respiratory symptoms or confirmed viral respiratory infection, the<br>number of exacerbations associated with viral respiratory infection, the proportion of asthma-control days, episodefree, symptom-free, and rescue-free days.