Efficacy and Safety Study in Subjects With Asthma

NCT ID: NCT00980200

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-01-31

Brief Summary

The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.

Detailed Description

The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an FEV1 of between 40-85% of predicted normal and with airway reversibility as demonstrated by an increase in FEV1 of ≥12% and ≥200ml .

Efficacy assessments include 24-hour serial lung function testing. Safety assessments include incidence of adverse events and measurement of vital signs.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

C/E/A/B/D

GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD/GW642444 Dose 3 QD

Group Type: EXPERIMENTAL

Dose 2 QD

Intervention Type: DRUG

QD once daily

D/C/E/A/B

GW642444 Dose 3 QD/GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD

Group Type: EXPERIMENTAL

Dose 3 QD

Intervention Type: DRUG

QD once daily

A/B/C/D/E

placebo/GW642444 Dose 1 BD/GW642444 Dose 2 QD/GW642444 Dose 3 QD/GW642444 Dose 4 QD

Group Type: EXPERIMENTAL

placebo

Intervention Type: DRUG

placebo

B/A/D/E/C

GW642444 Dose 1 BD/placebo/GW642444 Dose 3 QD/GW642444 Dose 4 QD/GW642444 Dose 2 QD

Group Type: EXPERIMENTAL

Dose 1 BD

Intervention Type: DRUG

BD twice daily

E/D/B/C/A

GW642444 Dose 4 QD/GW642444 Dose 3 QD/GW642444 Dose 1 BD/GW642444 Dose 2 QD/placebo

Group Type: EXPERIMENTAL

Dose 4 QD

Intervention Type: DRUG

QD once daily

Interventions

Dose 4 QD

QD once daily

Intervention Type: DRUG

Dose 3 QD

QD once daily

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Dose 2 QD

QD once daily

Intervention Type: DRUG

Dose 1 BD

BD twice daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Outpatient
• ≥18 years of age at Visit 1
• Male or Eligible Female
• Diagnosis of asthma at least 12 weeks prior to Visit 1
• Disease reversibility
• Current anti-asthma therapy
• Appropriately signed and dated informed consent has been obtained
• Able to comply with all the study requirements

Exclusion Criteria

• History of Life-Threatening Asthma
• No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
• No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation
• Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate
• History of severe milk protein allergy
• Non-compliance with study medication and other study-related requirements
• No use of inhaled tobacco products within the past three months or historical use of 10 pack years or more
• Administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Cypress, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Bethesda, Maryland, United States

GSK Investigational Site

Rolla, Missouri, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Orangeburg, South Carolina, United States

GSK Investigational Site

Boerne, Texas, United States

Countries

United States

References

Sterling R, Lim J, Frith L, Snowise NG, Jacques L, Haumann B. Efficacy and optimal dosing interval of the long-acting beta(2) agonist, vilanterol, in persistent asthma: a randomised trial. Respir Med. 2012 Aug;106(8):1110-5. doi: 10.1016/j.rmed.2012.03.007. Epub 2012 Apr 19.

Reference Type: BACKGROUND

PMID: 22520084 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

113310

Identifier Type: -

Identifier Source: org_study_id