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Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01248975
First Posted: November 25, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 [ Time Frame: at the end of the 6 week treatment period. ]

Secondary Outcome Measures:
  • • 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. ]
  • • Daily PM PEF [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period. ]
  • • Daily (average of AM and PM) [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period ]
  • • Daily asthma symptom score [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period. ]
  • • Daily rescue salbutamol use [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period. ]
  • • Percentage of symptom-free days [ Time Frame: during the last 3 weeks of the 6 week treatment period. ]
  • • Percentage of symptom-free nights [ Time Frame: during the last 3 weeks of the 6 week treatment period. ]
  • • Percentage of rescue-free days [ Time Frame: during the last 3 weeks of the 6 week treatment period. ]
  • • Percentage of rescue-free nights [ Time Frame: during the last 3 weeks of the 6 week treatment period. ]
  • • Percentage of nights without awakenings due to asthma [ Time Frame: during the last 3 weeks of the 6 week treatment period. ]
  • • Proportion of subjects withdrawn due to lack of efficacy [ Time Frame: during the last 3 weeks of the 6 week treatment period. ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248975


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, 49027
GSK Investigational Site
Dnipropetrovsk, Ukraine, 49051
GSK Investigational Site
Donetsk, Ukraine, 83099
GSK Investigational Site
Ivano-Frankivsk, Ukraine, 76018
GSK Investigational Site
Kharkiv, Ukraine, 61035
GSK Investigational Site
Kharkiv, Ukraine, 61037
GSK Investigational Site
Kiev, Ukraine, 03680
GSK Investigational Site
Kiev, Ukraine, 3680
GSK Investigational Site
Kyiv, Ukraine, 02091
GSK Investigational Site
Kyiv, Ukraine, 02232
GSK Investigational Site
Kyiv, Ukraine, 03115
GSK Investigational Site
Kyiv, Ukraine, 04107
GSK Investigational Site
Zaporizhia, Ukraine, 69035
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 114387
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 114387
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 114387
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 114387
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 114387
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 114387
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 114387
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01248975     History of Changes
Other Study ID Numbers: 114387
First Submitted: November 24, 2010
First Posted: November 25, 2010
Last Update Posted: October 12, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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
Montelukast
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Glucocorticoids
Hormones
Sympathomimetics