None listed
Conditions
Interventions
Preparation Period: This group will continue with its treatment of usual inhaled corticosteroids (ICS) + Fluticasone Propionate / Salmeterol Placebo, 2 inhalations in the morning and 2 in the night + Fluticasone propionate, 2 inhalations in the morning and 2 in the evening + Salbutamol in case of crisis on demand. This scheme will be administered for 2 weeks.
Period of Random Treatment: This group will suspend its ICS and start with: Fluticasone Propionate / Salmeterol, at a dose of 50/25 mcg
Preparation Period: This group will continue with its treatment of usual inhaled corticosteroids (ICS) + Fluticasone Propionate / Salmeterol Placebo, 2 inhalations in the morning and 2 in the night + Fluticasone propionate, 2 inhalations in the morning and 2 in the evening + Salbutamol in case of crisis on demand. This scheme will be administered for 2 weeks.
Period of Random Treatment: This group will suspend its ICS and start with: Fluticasone Propionate / Salmeterol Placebo, 2 inhalations
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type of Subject: The subject must be treatable on an outpatient basis. 2. Age: The subject must be 4-11 years of age in Visit 1. 3. Sex: Male or female pre-menarche. 4. Illness: All subjects must have a diagnosis of asthma that required pharmacotherapy prescribed by the doctor for at least two months before Visit 1. 5. Severity of Disease: At Visit 1, subjects 6-11 years of age should demonstrate a baseline morning clinical FEV1 pre-albuterol> 60% of the predicted Polgar value and subjects of 4 and 5 years of age should demonstrate a pre-albuterol basal AMF morning mat> 60% of the value Predicted Polgar. 6. Reversibility Component: A subject must have historical documentation of an increase in FEV1 or FEM of> 12% within 30 minutes after the administration of albuterol or levalbuterol within 24 months before Visit 1. 7. Concurrent anti-asthma therapy: Subjects are eligible to participate in the trial if they have been using an inhaled corticosteroid at a consistent dose for at least one month prior to Visit 1. 8. All subjects should be able to replace their short-acting B2-agonist with the aerosolized albuterol. 9. Maximum Flow Meter / Journal Book: The subject should be able to use the maximum flow meter supplied in the study and the subject / caregiver should be able to keep the record in the journal book. 10. Subjects (6-11 years of age) should be able to adequately perform the spirometry maneuver and maintain effort for at least 3 seconds.
Exclusion criteria
Exclusion criteria: 1. Life-threatening asthma: The subject should not have potentially fatal asthma. 2. Medications for asthma: Medications prohibited for asthma listed should not have been used before Visit 1 during the required interval and should not be taken during the study. 3. Corticosteroid therapy: The use of any medication with corticosteroids that is not the study medication is prohibited. 4. Excluded medications: Except where otherwise indicated, concurrent use of any prescription medication with or without a prescription that may affect the course of asthma, or that interacts with other medications required by this protocol, will not be permitted during the study. . 5. Immunosuppressive Drugs: The use of immunosuppressive drugs will not be allowed. 6. Concurrent diseases / abnormalities: Historical or current evidence of clinically significant, uncontrolled disease. 7. Varicella: A subject will not be eligible if they have chickenpox, or have been exposed in the last three weeks and are not immune. 8. Pharmacological Allergy: Any immediate or delayed hypersensitivity to a B2-agonist, sympathomimetic or intranasal, inhaled, or systemic corticosteroid therapy. 9. Infections: Sinus, middle ear, oropharynx, upper or lower respiratory tract infections within two weeks prior to Visit 1 that required the use of antibiotics or that were accompanied by symptoms of worsening asthma. 10. Use of tobacco. 11. Clinical laboratory abnormalities: Clinically significant abnormal laboratory tests during Visit 1. 12. ECG: The subject is not eligible if they have an abnormal, clinically significant ECG or a QTc interval> 449 msec. 13. Ophthalmological: History or presence of glaucoma and / or posterior subcapsular cataracts. 14. Research Drugs: Any investigational drug used for any indication is prohibited within 30 days prior to Visit 1. 15. Attendance: A subject will not be eligible if he / she or his parents or legal guardians have any illness, disability, or geographic location that could impede compliance with any aspect of the study protocol or scheduled visits to the study center. 16. Informed Consent: A subject will not be eligible if he / she or his parents or legal representatives have a history of psychiatric illness, intellectual disability, low motivation, substance abuse, or other conditions that limit the validity of informed consent to participate in This studio. 17. Affiliation with the investigator´s center: A subject will not be eligible for this study if he / she is an immediate member of the family of the participating researcher, sub-investigator, study coordinator, or employee of the participating investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Evaluation of any undesirable medical event in a patient, associated with the use of the research product Criterion 2: An independent cardiologist will be responsible for providing the measurements of the QT intervals, heart rate and an interpretation of the ECG, qualifying it as Normal or Abnormal. Criterion 3: Panels of hematology and serum chemistry. Criterion 4: 24-hour urine samples timed for the excretion of urinary cortisol and creatinine. Criterion 5: The subject must remain seated at least 5 minutes before taking the measurement. Blood pressure (systolic and diastolic) will be taken before the administration of albuterol (salbutamol). Criterion 6: A qualified professional will perform an examination of the oropharynx for clinical evidence of infection. If there is clinical evidence of oral infection, a culture should be performed and appropriate therapy instituted. Criterion 7: Clinical evaluation of any worsening of asthma requiring intervention, hospitalization, or emergency treatment with asthma medications in addition to those allowed by the protocol. Criterion 8: Clinical determination of the presence of signs and symptoms of worsening asthma that requires treatment with asthma medications not allowed during the study. Measure:Security: 1) Adverse events. 2) 12-lead ECGs. 3) Laboratory tests. 4) 24-hour urinary cortisol excretion. 5) Blood pressure. 6) Findings of the oropharynx examination. 7) Exacerbations of asthma. 8) Percentage of subjects withdrawn due to worsening asthma. Timepoints:Criterion 1: Weeks 1, 2, 4, 8, 10 and 12. Criteria 2, 3 and 5: Before starting treatment, in week 12 and in case of discontinuation. Criterion 4: Week 10. Criterion 6: Weeks 1, 2, 4, 8 and 12. Criteria 7 and 9: When the event is presented. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: FEV1 will be measured with standard spirometry in children 6 to 11 years of age. Criterion 2: Maximum expiration flow (FEM), will be measured with a maximum flow meter, in children of 4 and 5 years of age. It should be done between 6 and 11 am, after retaining albuterol for 6 hours or more. Criteria 3 and 4: Journal of the Patient, which will be filled each morning by the subject / caregiver. The rating of asthma symptoms will be regarding its severity, on a scale of 0 to 5. Measure:1) FE1 AM. 2. FEM AM. 3) Rating of asthma symptoms in 24 hours. 4) Use of albuterol (salbutamol) for 24 hours. Timepoints:Criteria 1 and 2: Before starting treatment and in week 12 Criteria 3 and 4: Weeks 0, 1, 2, 4, 8 and 12. | — |
Countries
Austria, Canada, Chile, Costa Rica, Germany, Latovia, Lithuania, Mexico, Peru, Poland, Russian Federation, Spain, United States
Outcome results
None listed