None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Mometasone / Formoterol in metered dose inhaler (MDI) 200/10 mcg, IDB for 52 weeks.
Group name:GROUP 4 Type of group
This group will be treated with Fluticasone / Salmeterol in metered dose inhaler (MDI) 500/50 mcg, IDB for 52 weeks.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject must be at least 12 years of age, belong to any sex and race, and have a diagnosis of asthma of at least 12 months of evolution. 2. The subject must have been receiving a medium or high daily dose of ICS for at least 12 weeks before the Screening and must have maintained a stable asthma treatment regimen for at least 2 weeks before the Screening. 3. If, at the investigator´s discretion, the change in treatment for asthma that the subject is currently receiving does not entail any inherent harm, the subject must be willing to interrupt their prescribed treatment with ICS or ICS / LABA combination at the Visit of Start. 4. The subject must show evidence of reversibility within ios last 12 months or during the Selection Period. If the subject does not have historical reversibility, he or she must demonstrate an absolute FEV1 of ≥ 12% and ≥ 200 mL within 10 to 15 minutes after the administration of four salbutamol inhalations at Visit 1 or at any time before the visit. start. 5. In the Selection and Start, the FEV1 of the subject must be ≥ 50% projected, when all restricted medications have been suspended during the appropriate intervals. 6. Clinical analyzes performed at the Screening Visit must be within normal or clinically acceptable limits for the researcher / sponsor. The ECG performed at the Screening Visit must be clinically acceptable to the investigator. The chest X-ray done at the Screening Visit or within 12 months prior to the Screening visit must be clinically acceptable to the Investigator. 7. The subject (and the parent / guardian in the case of subjects under the legal age) must be willing to give written informed consent and be able to comply with the schedule of doses and visits. 8. Women of childbearing age should be using adequate contraception. The subjects must have begun to use the contraceptive method at least 3 months before the Selection, and must agree to continue using it throughout the course of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects demonstrating a change in absolute FEV1 of> 20% at any time. 2. Subjects that need to use> 12 inhalations per day of SABA via MDI or> 2 nebulizations per day with salbutamol 2.5 mg in 2 consecutive days, from the Selection Visit to the Start Visit. 3. Subjects who experience a clinical exacerbation of asthma at any time from the Screening Visit to the Start Visit. 4. Subjects who have been treated in emergency rooms or taken to the hospital for treatment of airway obstruction within the last 3 months. 5. Subjects who have ever needed a respirator due to respiratory failure secondary to asthma. 6. Subjects who have suffered an infection of the lower or upper respiratory tract within 2 weeks prior to the Screening and Start visits. 7. Subjects smokers or former smokers who have smoked within the previous year or have an accumulated smoking history of more than 10 years-pack. 8. Subjects with a clinically significant altered vital sign. 9. Subjects with evidence of clinically significant oropharyngeal candidiasis at the start with or without treatment. 10. Subjects with a clinically significant history of kidney, liver, cardiovascular, metabolic, neurological, ophthalmological, haematogenic, respiratory, gastrointestinal, cerebrovascular or other significant medical conditions or disorders that could interfere with the study, or require treatment that could interfere with the study. 11. Subjects who are known to have an allergy or intolerance to ICS, B2 agonists, or any of the excipients present in the medications used in the study. 12. Women who are breastfeeding, pregnant, or expect to become pregnant while participating in the study. 13. Subject known to use illicit drugs. 14. Subjects known to have HIV positive. 15. Subjects with a history and / or presence of intraocular pressure in one of the eyes of ≥ 22 mm Hg, glaucoma, and / or cataracts. 16. Subjects Unable to use the MF / F MDI inhaler or the Seretide inhaler. 17. Subjects who have been taking any of the restricted medications before the Selection without complying with the required pharmacological washout periods. 18. Subjects who can not comply with the provisions on permitted concomitant medications and prohibited medications. 19. No subject participating in this study may participate in the same study at another research center. You can not participate in another research study in any center at the same time you participate in this study. 20. Subjects should not be randomized in this study more than once. 21. No person directly related to the administration of this study may participate as a subject of the study. No family member of the research study staff will be able to participate in this study. 22. Subjects who have previously participated in a study with SCH 418131 (MF / F).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of adverse events, vital signs. Laboratory analysis: Hematology and biochemistry panels, urinalysis and serum pregnancy test 12-lead ECG. Ophthalmological evaluations: Discharge of cataracts and measurement of intraocular pressure. Measure:Number and percentage of all randomized subjects who reported adverse events. Timepoints:Adverse events, vital signs: Visit 1: Days -14 to -7. Visit 2: Day 1. Visit 3: Week 1. Visits 4-10: Weeks 4, 8, 12, 16, 20, 26 and 39. Visit 11: Weeks 52. Laboratory analysis, ECG: Visit 1: Days -14 to -7. Visit 2: Day 1. Visit 11: Weeks 52. Ophthalmological evaluations: Visit 1: Days -14 to -7. Visits 4-10: Weeks 4, 8, 12, 16, 20, 26 and 39. Visit 11: Weeks 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Average change in pulmonary function tests: Standard spirometry with measurement of FEV1, FEF, FVC, projected% of FEV1. Scales of diurnal and nocturnal evaluations, daily diurnal and nocturnal use of SABA, nocturnal awakenings for asthma that require the use of SABA, time elapsed until the first worsening of asthma, proportion of days without asthma, proportion of days without symptoms of asthma, proportion of nights without asthma: Obtained from the diaries filled by patients. Measure:Average change in pulmonary function tests. PEF morning and evening. Morning and evening symptom scores. Scales of diurnal and nocturnal evaluations. Day and night daily use of SABA. Night awakenings for asthma that require the use of SABA. Time elapsed until the first worsening of asthma. Proportion of days without asthma. Proportion of days without asthma symptoms. Proportion of nights without asthma. Timepoints:Average change in pulmonary function tests, recovery and review of subjects diaries: Visit 1: Days -14 to -7. Visit 2: Day 1. Visit 3: Week 1. Visits 4-10: Weeks 4, 8, 12, 16, 20, 26 and 39. Visit 11: Weeks 52. ; Outcome name:Health resources related to asthma: Measured by any of the following: o Unscheduled visits to the doctor s office. or Unscheduled home medical visits. o Visits to the emergency room. or International. o Days that missed school or work. Measure:Use of health resources related to asthma. Timepoints:Review of subjects diaries: Visit 1: Days -14 to -7. Visit 2: Day 1. Visit 3: Week 1. Visits 4-10: Weeks 4, 8, 12, 16, 20, 26 and 39. Visit 11: Weeks 52. | — |
Countries
Argentina, Chile, Ecuador, Guatemala, Mexico, Peru
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed