Study to Evaluate the Effect of Adding five different compounds to Fluticasone Propionate 100 mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects =12 Years of Age.

Phase 1

• Conditions: Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-019466-81-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Research & Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-12
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

- Age: 12 years of age or older
- Non-, former or current smokers with a documented smoking history of = 10 pack years
- Asthma diagnosis as defined by the National Institutes of Health
- Best FEV1 of 50% to <80% of the predicted normal value
- Post-albuterol FEV1/FVC ratio of >0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)
- = 12% and =200mL reversibility of FEV1
- Must have been using FP 100mcg inhalation powder BID for at least 2 weeks just prior to Visit 1.
- Must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol
- Must be able and willing to give written informed consent to take part in the study.
- Must be able and willing to comply with all aspects of the study including completion of daily e-Diary.
Are the trial subjects under 18? yes
Number of subjects for this age range: 41
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- History of life-threatening asthma
- Recent asthma exacerbation
- Concurrent respiratory disease
- Recent respiratory infection
- Liver disease
- Other concurrent diseases/abnormalities
- Oral candidiasis
- Drug allergy
- Milk protein allergy
- Immunosuppressive Medications
- Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1
- OATP1B1 substrates within 4 weeks of Visit 1
- Cytochrome P450 3A4 (CYP 3A4) Inhibitors
- Cytochrome P450 3A4 (CYP 3A4) Inducers
- Investigational Medications
- Compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol
- Affiliation with Investigator’s Site

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified