Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma
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Purpose
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled asthmatic subjects > or = 18 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 to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: FP/SAL 250/50mcg BID Drug: GSK2190915 200mg QD (AM) Drug: GSK2190915 100mg QD (AM) Drug: Montelukast 10mg QD (PM) Drug: Placebo tablets (2) (AM) Drug: Placebo capsule (PM) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Treatment, Three 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 300mg as Compared to Adding Montelukast 10mg or Placebo Tablets QD to Fluticasone Propionate/Salmeterol 250/50mcg Diskus BID |
- Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 [ Time Frame: at the end of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Daily trough (AM pre-dose and pre-rescue bronchodilator) AM PEF [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Daily PM PEF [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Daily (average of AM and PM) [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period ] [ Designated as safety issue: No ]
- • Daily asthma symptom score [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Daily rescue salbutamol use [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Percentage of symptom-free days [ Time Frame: during the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Percentage of symptom-free nights [ Time Frame: during the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Percentage of rescue-free days [ Time Frame: during the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Percentage of rescue-free nights [ Time Frame: during the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Percentage of nights without awakenings due to asthma [ Time Frame: during the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
- • Proportion of subjects withdrawn due to lack of efficacy [ Time Frame: during the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
| Enrollment: | 145 |
| Study Start Date: | December 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
|
Drug: FP/SAL 250/50mcg BID
FP/SAL 250/50mcg BID
Drug: GSK2190915 200mg QD (AM)
GSK2190915 200mg QD (AM)
Drug: GSK2190915 100mg QD (AM)
GSK2190915 100mg QD (AM)
Drug: Placebo capsule (PM)
Placebo capsule (PM)
|
|
Active Comparator: FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
|
Drug: FP/SAL 250/50mcg BID
FP/SAL 250/50mcg BID
Drug: Montelukast 10mg QD (PM)
Montelukast 10mg QD (PM)
Drug: Placebo tablets (2) (AM)
Placebo tablets (2) (AM)
|
|
Placebo Comparator: FP/SAL 250/50mcg BID plus placebo BID
P/SAL 250/50mcg BID plus placebo BID
|
Drug: FP/SAL 250/50mcg BID
FP/SAL 250/50mcg BID
Drug: Placebo tablets (2) (AM)
Placebo tablets (2) (AM)
Drug: Placebo capsule (PM)
Placebo capsule (PM)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 18 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
- For current and former smokers, a 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/SAL 250/50mcg 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
Contacts and Locations| Bulgaria | |
| GSK Investigational Site | |
| Pleven, Bulgaria, 5800 | |
| GSK Investigational Site | |
| Ruse, Bulgaria, 7000 | |
| GSK Investigational Site | |
| Varna, Bulgaria, 9010 | |
| Poland | |
| GSK Investigational Site | |
| Bialystok, Poland, 15-084 | |
| GSK Investigational Site | |
| Lodz, Poland, 93-329 | |
| GSK Investigational Site | |
| Tarnow, Poland, 33-100 | |
| Ukraine | |
| GSK Investigational Site | |
| Dnipropetrovsk, Ukraine, 49051 | |
| GSK Investigational Site | |
| Dnipropetrovsk, Ukraine, 49027 | |
| GSK Investigational Site | |
| Donetsk, Ukraine, 83099 | |
| GSK Investigational Site | |
| Ivano-Frankivsk, Ukraine, 76018 | |
| GSK Investigational Site | |
| Kiev, Ukraine, 3680 | |
| GSK Investigational Site | |
| Kiev, Ukraine, 03680 | |
| GSK Investigational Site | |
| Kyiv, Ukraine, 02091 | |
| GSK Investigational Site | |
| Kyiv, Ukraine, 03115 | |
| GSK Investigational Site | |
| Kyiv, Ukraine, 02232 | |
| GSK Investigational Site | |
| Kyiv, Ukraine, 04107 | |
| GSK Investigational Site | |
| Zaporizhia, Ukraine, 69035 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01248975 History of Changes |
| Other Study ID Numbers: | 114387 |
| Study First Received: | November 24, 2010 |
| Last Updated: | June 14, 2012 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Ukraine: State Pharmacological Center of Ministry of Health of Ukraine Poland: Ministry of Health & Social Welfare |
Keywords provided by GlaxoSmithKline:
|
asthma GSK2190915 |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Montelukast Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013