Efficacy and Safety Study in Subjects With Asthma
A Multi-center, Randomized, Double-blind, Placebo-controlled, Five Period Cross-over Study to Evaluate the Efficacy and Safety of Selected Doses and Dose Intervals of GW642444 Administered Via a Novel Dry Powder Inhaler (NDPI) in Subjects ≥18 Years of Age With Persistent Asthma
1 other identifier
interventional
75
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Sep 2009
Shorter than P25 for phase_2 asthma
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 17, 2009
CompletedFirst Posted
Study publicly available on registry
September 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
August 7, 2013
CompletedJanuary 30, 2017
December 1, 2016
4 months
September 17, 2009
June 6, 2013
December 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the mean of the FEV1 values obtained at the last two scheduled time points at the Day 7 clinic visit (i.e., 11 and 12 hours after the morning dose, or 23 and 24 hours after the evening dose). Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants is fitted as a random effect, and the period Baseline measurement is included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.
Baseline and Day 7 of the treatment period (up to Study Day 63)
Secondary Outcomes (1)
Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period
Baseline and Day 7 of the treatment period (up to Study Day 63)
Study Arms (5)
C/E/A/B/D
EXPERIMENTALGW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD/GW642444 Dose 3 QD
D/C/E/A/B
EXPERIMENTALGW642444 Dose 3 QD/GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD
A/B/C/D/E
EXPERIMENTALplacebo/GW642444 Dose 1 BD/GW642444 Dose 2 QD/GW642444 Dose 3 QD/GW642444 Dose 4 QD
B/A/D/E/C
EXPERIMENTALGW642444 Dose 1 BD/placebo/GW642444 Dose 3 QD/GW642444 Dose 4 QD/GW642444 Dose 2 QD
E/D/B/C/A
EXPERIMENTALGW642444 Dose 4 QD/GW642444 Dose 3 QD/GW642444 Dose 1 BD/GW642444 Dose 2 QD/placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (9)
GSK Investigational Site
Cypress, California, 90630, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Bethesda, Maryland, 20814, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Boerne, Texas, 78006, United States
Related Publications (1)
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.
PMID: 22520084BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2009
First Posted
September 18, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
January 30, 2017
Results First Posted
August 7, 2013
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.