Phase 2 Completed N=162 Randomized Quadruple-blind Treatment

Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age

Asthma

Source: ClinicalTrials.gov NCT01156792 ↗

Enrolled (actual)

162

Serious AEs

0.2%

Results posted

Feb 2017

Primary outcomePrimary: Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period — 2.36; 2.39; 2.40; 2.42 Liters (L) — p==0.268

Summary

The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment. The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment.

Outcome Measures

Outcome	Result	p-value
PRIMARY Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period	2.36; 2.39; 2.40; 2.42; 2.43	=0.268
SECONDARY Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period	349.19; 350.14; 354.96; 354.17; 361.33	=0.751
SECONDARY Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period	354.06; 355.71; 359.16; 358.88; 364.35	=0.563
SECONDARY Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups	352.37; 356.16; 356.52	—
SECONDARY Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period	2.26; 2.26; 2.15; 2.22; 2.25	=0.957
SECONDARY Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period	2.17; 2.14; 2.03; 2.09; 2.08	=0.811
SECONDARY Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period	30.84; 33.51; 36.14; 34.88; 35.45	=0.285
SECONDARY Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period	37.21; 38.22; 40.55; 37.70; 38.47	=0.668
SECONDARY Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period	40.44; 42.43; 42.59; 42.77; 41.96	=0.367
SECONDARY Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period	45.12; 45.69; 48.79; 45.32; 43.98	=0.789
SECONDARY Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period	37.21; 38.22; 40.55; 37.70; 38.47	=0.668
SECONDARY Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period	9; 5; 3; 7; 5	=0.408

Eligibility Criteria

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 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.

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

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Data sourced from ClinicalTrials.gov (NCT01156792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.