None listed
Conditions
Interventions
Groupo 1 Type of group
Fluticasone Furoate 110mcg daily for 52 weeks
Group name:Group 2 Type of group
placebo nasal spray for 52 weeks
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Signed and dated consent granted by the subject´s parent / legal guardian. Appropriate provisions for the consent of the minor must be considered, in accordance with the requirements of the ERB and any local regulations. • Age: from 5 to less than 7.5 years for girls and from 5 to less than 8.5 years for boys in Visit 1. • Subjects must have a diagnosis and history of perennial allergic rhinitis (RAP) • At Visit 2, the daily rTNSS rating on any of the 4 days of the last 7 days prior to Visit 2 must be> 5. Subjects should avoid using rescue medication during the 7 days prior to Visit 2. • Pre-puberty: A determination of Tanner´s stage equivalent to 1 for all classifications, evaluated by the researcher during each of the five baseline visits (from Visit 1 to Visit 5). The same researcher must perform this evaluation during the study for a particular subject, as far as possible, to ensure the consistency of the evaluation. The details are included in the SPM. • The current measurement of height using a standardized stadiometer is within the 3rd and 97th percentiles according to the CDC and any standard table of local longitudinal height for age and gender, as indicated in the SPM (from the Visit 1 to Visit 5). • Body weight and body mass index between the 3 rd and 97 th percentile according to the CDC standards for the United States and any local standard, as assessed during each of the five baseline visits (from Visit 1 to Visit 5). The CDC rules for the United States are provided in the SPM. • Therapeutic compliance: The subject´s parent or guardian knows how to read and both the subject and the parent or guardian consider themselves capable of following all the study procedures, including the correct administration of the study drug, the daily filling of the electronic diary, laboratory evaluations at the clinic and home collection of 24-hour urine during the 76 weeks of participation in the study (from Visit 1 to Visit 5).
Exclusion criteria
Exclusion criteria: • Antecedents or evidence of abnormal growth. • Any previous or current condition that affects growth, including sleep disorders. • Asthma, with the exception of mild intermittent asthma [National Asthma Education and Prevention Program, 2007] (Note: Subjects will be allowed to use inhaled short-acting beta agonists only as needed.) • History of nasal or sinus surgery, perforation of the nasal septum or severe obstruction of the nose (for example, nasal polyps). • Any other significant concomitant medical condition. Significant is defined as any disease that, in the opinion of the investigator, would jeopardize the safety of the subject through participation in the study, or that could confuse the interpretation of the results of the study if the disease or condition is exacerbated during the same . (Visit 1 to Visit 5) • Previous or current use of any medication / treatment to affect growth, including, among others, methylphenidate hydrochloride, thyroid hormone, growth hormone, anabolic steroids, calcitonin, estrogens, progestins, bisphosphonates, anticonvulsants or antacids that bind to phosphate. (Visit 1 to Visit 5). • Use of corticosteroids, defined as follows: Inhaled, intranasal or high-potency topical corticosteroids (including dermatological, ophthalmologic and otic corticosteroids) within 6 weeks prior to Visit 1 or during the baseline period (Visit 1 to Visit 5). Systemic corticosteroids (including oral and injectable) within 12 weeks prior to Visit 1 or during the baseline period (from Visit 1 to Visit 5. • The use of other allergy medications within an appropriate time frame in relation to Visit 1 to allow the medication to be eliminated or stop producing an effect, as well as during the baseline period (from Visit 1 to Visit 5) ) • Immunotherapy initiated or adjusted within 30 days prior to the Visit it during the baseline period (from Visit 1 to Visit 5), although it should be taken into account that significant changes in dose, concentration, or dilution during the study. • Use of immunosuppressive medications 8 weeks prior to selection or during the baseline period (from Visit 1 to Visit 5) of the study. • Use of any medication that significantly inhibits the CYP3 A4 enzyme of the cytochrome P450 subfamily, including ritonavir and ketoconazole. (Visit 1 to Visit 5) • Allergy / Intolerance: Known hypersensitivity to corticosteroids or to any nasal spray excipient, Known hypersensitivity to antihistamine or decongestant provided for aggravated symptoms of rhinitis during the performance of the study. • Exposure to varicella or measles in the three weeks prior to selection or during the baseline period (from Visit 1 to Visit 5), if not immunized. A diagnosis of varicella or measles during the basal period is also a reason for exclusion. • Recent exposure to an experimental study drug within 30 days prior to Visit 1. • Link with the research center. • Findings of a clinical laboratory test of selection (Visit 1) that presents a clinically significant abnormality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:on the basis of the analysis of covariance, with adjustments for basal growth rate, age, gender and country. Measure:Comparison of growth rates between FFNS 110mcg and placebo throughout the treatment period Timepoints:During treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events (incidence, type, severity) will be evaluated after Visit 1 at each visit during the study. Measure:Frequency and type of adverse events Timepoints:During treatment ; Outcome name:Results of biochemistry exams, hematology, urinalysis Measure:Variation in Results of clinical laboratory analyzes Timepoints:During the study | — |
Countries
France, Italy, Peru
Contacts
Public ContactRosela Garcia
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed