A Randomized Double-Blind Placebo-Controlled, Parallel-Group, Multicenter, Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder 25mcg, 50mcg, 100mcg, and 200mcg Administered Once Daily in the Morning and Fluticasone Propionate 100mcg BID via DISKUS Inhalation Powder compared with Placebo for 8 Weeks in Adolescent and Adult Subjects (=12 years old) with Persistent Asthma Symptomatic on Non-ICS Therapy

Not Applicable

Conditions: -J459 Asthma, unspecified
Asthma, unspecified
J459

Registration Number: PER-040-05

Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Spirometry: Electronically generated flow curves will be measured and the highest measure of 3 acceptable measures will be taken<br>Measure:Primary efficacy of the treatment: Change of the minimum FEV1<br>Timepoints:Basal and at 8 weeks<br>

Secondary Outcome Measures

Name	Time	Method

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