None listed
Conditions
Interventions
Group 1 Type of group
100 ug of inhaled Mometasone Furoate, daily for 12 weeks
Group name:Group 3 Type of group
Fomeate of Mometasona Placebo daily for 12 weeks
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • The subjects must be between 4 and 11 years of age and belong to any sex and race. • Subjects must have had a diagnosis of asthma for at least 6 months. • The subject´s FEVi must be greater than or equal to 60% and less than or equal to 85% of the normal value projected on the Selection (Visit 1) and Start (Visit 2) visits, when all restricted medications have been withdrawn during the specified intervals. • The subjects must show signs of an increase in the absolute FEVi of at least 12% after the selection reversibility test. Any historical reversibility carried out and documented in the research center within 12 months prior to the Selection is admissible. • Subjects must have been using corticosteroids daily for at least 60 days before Screening • Clinical laboratory tests must be within normal or clinically acceptable limits for the Investigator / Sponsor. • Subjects should not present any significant clinical disease (other than asthma), which may interfere with the study evaluations. • The subjects and their parents / guardians must be willing to give informed consent in writing and able to comply with the plans of visits and doses as well as the requirements of the study. • Subjects and their parents / guardians should agree to inform their usual treating physician (if not the Study Investigator) of their participation in this study. • Female subjects must be premenarchal.
Exclusion criteria
Exclusion criteria: • Subjects whose clinical condition requires the daily use of nebulized p agonists or the use of any long-acting inhaled p agonist. The use of long-acting p agonists is prohibited during the study. • Subjects who have required hospitalization for asthma control within the previous 3 months. • Subjects who must have been assisted with a ventilator due to respiratory insufficiency secondary to asthma in the last 5 years. • Subjects who have used systemic corticosteroids for more than 15 days in the six months prior to Screening. • Subjects who have been hospitalized for the management of an airway obstruction, on two or more occasions in the last 6 months. • Subjects that show an increase or decrease of> 20% in FEVi between the Selection and Start visits. • Subjects that require the use of> 12 aspirations per day of rescue medication (or three nebulizer treatments) on any 2 consecutive days between the Selection and the Start. • Subjects who have suffered an infection (viral or bacterial) of the lower or upper respiratory tract in the 2 weeks prior to the Screening and Start visits. • Subjects treated with increasing doses of immunotherapy, oral or short cycle immunotherapy for the treatment of rhinitis. • Subjects allergic to corticosteroids or agonists b. • Subjects with clinically significant signs of bronchiectasis or cystic fibrosis. • Subjects with a significant history of renal, hepatic, cardiovascular, metabolic, neurological, hematological, respiratory, gastrointestinal, cerebrovascular, psychiatric, immunological or other significant diseases or disorders that, in the opinion of the Investigator, could interfere with the study, or require a treatment that could interfere with the study. Specific examples include subjects with a history of glaucoma and / or subsequent subcapsular cataracts, insulin-dependent diabetes mellitus, cancer, active hepatitis. Other diseases that are well controlled and stable and that are treated with appropriate medications can be accepted after consultation with the Sponsor. • Subjects with a vital sign based! clinically relevant abnormal. • Subjects with clinically significant abnormal ECG at the Screening Visit or in the preceding 30 days. • Subjects presenting clinically significant abnormalities on chest radiographs, at the Selection Visit or within the last year. • Subjects with signs (on physical examination) of clinically significant oropharyngeal candidiasis. • Subjects who have been taking any of the restricted medications before the Selection • Subjects who can not comply with the prohibitions regarding concomitant medication • Subjects unable to use the DPI device. • Subjects unable to effectively use a maximum flow meter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Pulmonary function tests Measure:Change in the baseline value of % of projected FEV1 and in the primary moment (last visit). Timepoints:During the 12 weeks of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Pulmonary function tests Measure:FVC Timepoints:During the 12 weeks of the study ; Outcome name:Pulmonary function tests Measure:FEF 25-75% Timepoints:During the 12 weeks of the study ; Outcome name:Evaluation of the response to treatment by physical examination and pulmonary function tests. Measure:Response to treatment Timepoints:12 weeks ; Outcome name:Physical examination Measure:Presence of diurnal and nocturnal asthma symptoms recorded in AM and PM Timepoints:12 weeks ; Outcome name:Life quality evaluation Measure:Number of night awakenings due to asthma that required Proventil- HFA Timepoints:On weeks 8 and 12 ; Outcome name:Collection of the study inhaler (s); Delivery / Return of rescue medication, as needed Measure:Amount of Proventil-HFA used as rescue medication registered daily. Timepoints:Week 12 ; Outcome name:Return / Review of the diary Measure:Number of treatments with nebulized beta agonists registered daily. Timepoints:During the 12 weeks | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed