None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Fomeate Mometasone, nasal spray, at a dose of 50 mcg for each spray, in each nostril, BID, for a total of 200 mcg per day, for 8 weeks.
Group name:GROUP 2 Type of group
This group will be treated with Furoato de Mometasona Placebo, nasal spray, 1 spray, in each nostril, BID, for 8 weeks.
Sponsors
SCHERING PLOUGH DEL PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1729/5000 1. Subjects and their parents must demonstrate their willingness to participate in the study and comply with these procedures. Parents must sign an informed written consent. 2. Children from 2 to 11 years of age of both genders and any race. 3. The subjects and the parents of the subjects must understand and be able to adhere to the dosing and visiting programs, and agree to record the scores of the severity scales of the symptoms, medication hours and concomitant medications with accuracy and consistently in a newspaper. 4. Children with a history of adenoid hypertrophy for at least 3 months without response to previous medical treatment. 5. The size of the adenoid tissue must have been qualified by a nasopharyngoscopic examination as Grade III or IV Adenoid / Coana A / C index in the baseline (between 50% and 100% of obstruction). 6. The score of the Total Syndrome Severity Scale must be in the baseline with a minimum score of 8 points AM or PM. 7. The criteria for the OME in the study were the following: a) Persistent middle ear discharge documented by otoscopic examination for a minimum of 3 months. b) Middle ear pressure less than -150 mm H20. c) Jerger tympanogram type B flat and / or. d) Mild-moderate conductive hearing loss in the audiometry supporting the diagnosis of OME. 8. The parents of the subjects must understand and be able to adhere to the dosing and visitation programs, and agree to record the symptom severity scores, medication times, concomitant medications and adverse events accurately and consistently in a diary.
Exclusion criteria
Exclusion criteria: 1. Subjects with previous surgery of adenoid hypertrophy with or without placement of ventilation tubes 2. Subjects with previous treatment with ICS or systemic steroids in the previous 30 days. 3. Subjects with Morbid Obesity. 4. Subjects who have not complied with the designated washout periods for any of the prohibited drugs and subjects who have used any investigational product within 30 days or any antibody to the allergy within 90 days prior to enrollment. 5. Subjects who have any clinically significant deviation from the normal on the physical examination that, in the Investigator´s judgment, may interfere with the study´s assessments or affect the subject´s safety. 6. Subjects who are allergic or who have an idiosyncratic reaction to corticosteroids. 7. Subjects with signs and symptoms of acute or chronic bacterial rhinosinusitis. 8. Subjects with a documented immunodeficiency condition. 9. Subjects having nasal structural abnormalities, including large nasal polyps and notable septum deviation, which significantly interferes with nasal airflow. 10. Subjects with any clinically significant metabolic, cardiovascular, neurological, hematological, gastrointestinal, cerebrovascular or respiratory disease, or any other disorder. in the opinion of the Investigator, may interfere with the evaluations of the study or affect the safety of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Nasopharyngoscopy, where Adenoid / Coana ratios (A / C index) are evaluated, qualifying them as grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Measure:Primary Efficacy: Reduction of the size of the adenoids with respect to the baseline value. Timepoints:Day 1 and in weeks 4, 8 and 24 (Follow-up). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: This scale evaluates the symptoms of (snoring, nasal obstruction, nasal discharge, oral breathing, pain in the ear and respiratory distress) evaluated by parents or patients, regarding their frequency and severity. Criteria 2 and 3: These specific evaluations will be carried out by specialized audiologists. Criterion 4: This questionnaire (PSQ) is composed of 22 variables, divided into 3 factors: Snoring, drowsiness and behavior. Criterion 5: The PedsQL 4.0 scale consists of 23 items and measures the quality of life related to health in children and adolescents. The Specific Question of the Quality of Pediatric Life (OSA-18), consists of a 7-point evaluation, which evaluates the frequency of specific symptoms during the previous 4 weeks. Criterion 6: Carried out by a specialized doctor. Measure:Secondary Efficacy: 1) Improvement in the AM and PM Symptom Scale. 2) Improvement in bilateral tympanogram measurements. 3) Improvement in the measurements of Rhinomanometry, Acoustic Rhinometry and Pure Tone Audiometry. 4) Improvement in the Pediatric Sleep Questionnaire (PSQ). 5) Improvement in the Pediatric QoL Questionnaire (PedsQL) and Pediatric OSA-18. 6) Improvement in the Otoscopic and Rhinoscopic examination. Timepoints:Criteria 1, 3, 4 and 6: Day 1 and in weeks 4, 8, 16 and 24 (Follow-up). Criteria 2 and 5: Day 1 and in weeks 4, 8 and 24 (Follow-up). ; Outcome name:Medical evaluation of any undesirable medical occurrence in a subject who was administered a pharmaceutical, biological (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. On these the severity and its probable relation with the investigational medication will be evaluated. Measure:Incidence of adverse events. Timepoints:Day 1 and weeks 4, 8, 16 and 24. | — |
Countries
Mexico, Venezuela
Contacts
Public ContactOscar Barrenechea
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed