None listed
Conditions
Interventions
Group 1 Type of group
After being selected, the patients will go through a period of 28 days +/- 2 days in which the B2 agonist of regular use will be replaced by albuterol and corticosteroid controllers will not be used. Subsequently they will be administered with GW685698X 25 mcg and placebo of fluticasone propionate DISKUS one inhalation each in the morning plus placebo of fluticasone propionate DISKUS an inhalation at night. This regime will be maintained for 56 days
Group name:Group 6 Type of group
After being selected, patients will go through a period of 28 days +/- 2 days in which the B2 agonist of regular use will be replaced by albuterol and corticosteroid controllers will not be used. Subsequently they will be administered with placebo of GW685698X 200 mcg and placebo of fluticasone propionate via DISKUS one inhalation each in the morning plus placebo of fluticasone propionate via DISKUS one inhalation at night. This regime will be maintained for 56 days
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type of Subject: Outpatient 2. Age: 12 years of age or older at the Visit 3. Sex: Male or Female eligible. 4. Asthma Diagnosis: The asthma definition of the National Institutes of Health is used. 5. Severity of the Disease: The best FEV1 of 50% -80% of the predicted value. 6. Reversibility of the disease: Reversibility demonstrated at> 12% and> 200mL of FEV1 within 30 minutes after 2-4 aerosol albuterol / salbutamol inhalations. 7. Current Anti-asthma Therapy: Subjects must have been using a non-corticosteroid or short-acting R2 agonist bronchodilator. 8. Short Action b2 agonists: All subjects should be able to replace the short-acting B2 agonist with albuterol / salbutamol HFA aerosol for inhalation. 9. Informed Consent: All subjects must be able and willing to provide their informed consent to participate in the study. 10. Compliance: Subjects must be able to meet all the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. History of Asthma that endangers life. 2. Respiratory infection. 3. Exacerbation of Asthma: Any exacerbation of asthma requiring oral corticosteroids at 3 months of Visit 1. 4. Concurrent Respiratory Disease. 5. Other Diseases / Concurrent Abnormalities: The subject should not have uncontrolled clinically significant conditions or diseases. 6. Oropharyngeal examination: A subject will not be eligible for the preparation if his oropharyngeal examination is abnormal. 7. Research drugs: A subject must not have used investigational drugs within 30 days before. 8. Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta agonist sympathomimetic drug, or intranasal, inhaled, or systemic corticosteroid therapy. 9. Allergy to the Milky Protein. 10. Immunosuppressive drugs. 11. 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 damage compliance with any aspect of this study protocol, scheduled visits to the study center and non-compliance with medications or study procedures. 12. Smoking. Subjects can not use tobacco products in the period of the previous year. 13. Affiliation of the Investigator´s Site: The subjects will not be eligible for it if they are members of the immediate family of the Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator. 14. Use of Corticosteroids. 15. Use of Potent Cytochrome P450 34A Inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Spirometry: Electronically generated flow curves will be measured and the highest measure of 3 acceptable measures will be taken Measure:Primary efficacy of the treatment: Change of the minimum FEV1 Timepoints:Basal and at 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Annotations of the diary of the patients of morning results of measurements of the Flow Peak Meter Measure:Average change from baseline in morning minimum FEP Timepoints:Every day of the 8 weeks of treatment ; Outcome name:Annotations of the diary of the patients of evening results of measurements of the Flow Peak Meter Measure:Average change from baseline in evening minimum FEP Timepoints:Every day of the 8 weeks of treatment ; Outcome name:Annotations of the diary of the patients of measurement results of the Flow Peak Meter Measure:Average change from baseline in the percentage of 24-hour periods free of symptoms Timepoints:Every day of the 8 weeks of treatment ; Outcome name:Annotations of the diary of the patients of measurement results of the Flow Peak Meter Measure:Average change from baseline in the percentage of 24-hour freem periods without rescue Timepoints:Every day of the 8 weeks of treatment ; Outcome name:Annotations of the diary of the patients of measurement results of the Flow Peak Meter Measure: 42/5000 The number of withdrawals due to lack of efficiency Timepoints:Every day of the 8 weeks of treatment ; Outcome name:1) Incidence of adverse events: Clinical evaluation. 2) Examination of the oropharynx: Clinical evaluation. 3) Alterations in laboratory tests: serum biochemistry, complete hematology and urine test 4) Cortisol excretion: Collection of urinary cortisol in 24 hours. 5) Evaluation of vital signs: Clinical evaluation. Measure:Clinical evaluation: Basal and weeks 1, 2, 4, 6, 8. Laboratory tests: Basal and week 8. Cortisol excretion: Weeks 0 and 8. Timepoints:Clinical evaluation: Basal and weeks 1, 2, 4, 6, 8. Laboratory tests: Basal and week 8. Cortisol excretion: Weeks 0 and 8. | — |
Countries
Czech Republic, Estonia, Peru, Slovakia
Outcome results
None listed