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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248975
• Other study ID #: 114387
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2010
• Last updated: November 23, 2016
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• FP/SAL 250/50mcg BID
FP/SAL 250/50mcg BID
• GSK2190915 200mg QD (AM)
GSK2190915 200mg QD (AM)
• GSK2190915 100mg QD (AM)
GSK2190915 100mg QD (AM)
• Montelukast 10mg QD (PM)
Montelukast 10mg QD (PM)
• Placebo tablets (2) (AM)
Placebo tablets (2) (AM)
• Placebo capsule (PM)
Placebo capsule (PM)

Locations

Country	Name	City	State
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Ruse
Bulgaria	GSK Investigational Site	Varna
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Tarnow
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Ivano-Frankivsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Zaporizhia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Bulgaria,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough (AM pre-dose and pre-rescue bronchodilator) FEV1		at the end of the 6 week treatment period.
Secondary	• Daily trough (AM pre-dose and pre-rescue bronchodilator) AM PEF		averaged over the last 3 weeks of the 6 week treatment period.
Secondary	• Daily PM PEF		averaged over the last 3 weeks of the 6 week treatment period.
Secondary	• Daily (average of AM and PM)		averaged over the last 3 weeks of the 6 week treatment period
Secondary	• Daily asthma symptom score		averaged over the last 3 weeks of the 6 week treatment period.
Secondary	• Daily rescue salbutamol use		averaged over the last 3 weeks of the 6 week treatment period.
Secondary	• Percentage of symptom-free days		during the last 3 weeks of the 6 week treatment period.
Secondary	• Percentage of symptom-free nights		during the last 3 weeks of the 6 week treatment period.
Secondary	• Percentage of rescue-free days		during the last 3 weeks of the 6 week treatment period.
Secondary	• Percentage of rescue-free nights		during the last 3 weeks of the 6 week treatment period.
Secondary	• Percentage of nights without awakenings due to asthma		during the last 3 weeks of the 6 week treatment period.
Secondary	• Proportion of subjects withdrawn due to lack of efficacy		during the last 3 weeks of the 6 week treatment period.

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.