A 6-month study to assess the safety and benefit of inhaled fluticasone propionate/salmeterol combination compared with inhaled fluticasone propionate in the treatment of children aged 4 to 11 years with asthma.
- Conditions
- AsthmaMedDRA version: 14.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-001643-79-LV
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6250
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
1. Informed consent
• Subject’s legal guardian must be able and willing to give written informed consent to take part in the study.
If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement.
• 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: 4-11 years of age at Visit 1
3. Gender: Male or eligible female. Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. All females of childbearing potential must have a negative urine pregnancy test result prior to randomization to continue in the study. Females who become pregnant during the course of the study will be discontinued and the pregnancy outcome followed
4. Asthma diagnosis: Asthma, defined by the regional asthma guidelines (i.e., NIH, GINA, etc.), for at least 6 months prior to Visit 1.
Asthma is defined as a chronic inflammatory disorder associated with airway hyperresponsiveness and reversible airways obstruction that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing.
If the subject is naïve to the study site, the subject/guardian must self-report a physician diagnosis of asthma and the investigator must confirm by review of medical history with the subject/guardian.
5. Ability to answer questions regarding asthma control (with assistance of his/her parents [guardians], if needed), and use a metered-dose inhaler (MDI) and DISKUS effectively.
6. In countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids (refer to the local product labels for varicella vaccine, ADVAIR DISKUS, and FLOVENT DISKUS) and/or varicella immunization is recommended for the age group, the subject must have a history of clinical varicella infection or recipient of a varicella vaccine before receiving any study drug. In those countries, subjects without a history of clinical varicella disease must receive varicella vaccine prior to randomization, and should follow standard guidelines regarding timing of second dose, if indicated.
7. Subject must have history of at least one occurrence (self-report by subject/guardian) of treatment with systemic corticosteroid [3 or more days of oral corticosteroid (OCS) or an equivalent depot corticosteroid injection] for an asthma exacerbation within the prior 12 months, excluding the 4 weeks immediately preceding Visit 1.
8. Currently being treated for asthma and no change in asthma therapy for the last 4 weeks from Visit 1 and Subjects must meet one of the following pre-study asthma medication, impairment domain (Childhood Asthma Control Test) and risk domain (asthma exacerbations) criteria to be eligible for enrolment.
• Subjects on SABA alone, LTRA, theophylline, or cromolyn as monotherapy with Childhood Asthma Control Test score =19 at Visit 1 and have had 2 or more asthma exacerbations in the previous year, or
• Subjects on low-do
1. 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. Unstable asthma at Visit 1.
3. Subjects who are currently receiving high-dose ICS or ICS/LABA therapy to treat asthma symptoms.
4. Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
5. Respiratory infection: Bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear (either culture-documented or suspected) that is not resolved at Visit 1 and that 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.
6. Subjects with only exercise-induced asthma are excluded from participation in this study.
7. Asthma exacerbation: An asthma exacerbation requiring systemic (tablets, suspension or injection) corticosteroids within 4 weeks of Visit 1 or more than 4 separate exacerbations in the last 12 months from Visit 1.
These include asthma exacerbations resulting from poor compliance with asthma medications.
Each asthma exacerbation must be separated by >7 days from the discontinuation of OCS to be considered an individual event.
8. Asthma hospitalization: Hospitalization for asthma within 4 weeks of Visit 1 or more than 2 hospitalizations (defined as overnight admission) for asthma in the last 12 months from Visit 1. Each hospitalization must be separated by >7 days to be considered an individual event (ED visits < 24 hours in duration are not considered hospitalizations).
9. Other current evidence of clinically significant uncontrolled diseases/conditions of any body or organ system. Significant is defined as any disease/condition that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
10. Neurological or psychiatric disease or history of drug or alcohol abuse (of a subject or his/her guardian) which in the opinion of the investigator could interfere with the subject’s proper completion of the protocol requirements excludes study participation.
11. Investigational medications: A subject must not have participated in an interventional study or used any investigational drug for any disease state within 30 days prior to Visit 1.
12. Drug allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medications.
13. Severe hypersensitivity to cow’s milk proteins. Any immediate hypersensitivity reaction such as urticaria, angioedema, rash, or bronchospasm to milk proteins.
14. Concomitant medications: Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, betaadrenergic blockers; phenothiazines, monoamine oxidase (MAO) inhibitors, or diureti
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method