Efficacy and Safety Study in Subjects With Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980200
• Other study ID #: 113310
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2009
• Last updated: August 29, 2013
• Start date: September 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß2 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Dose 4 QD
QD once daily
• Dose 3 QD
QD once daily
• placebo
placebo
• Dose 2 QD
QD once daily
• Dose 1 BD
BD twice daily

Locations

Country	Name	City	State
United States	GSK Investigational Site	Bethesda	Maryland
United States	GSK Investigational Site	Boerne	Texas
United States	GSK Investigational Site	Cypress	California
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rolla	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sterling R, Lim J, Frith L, Snowise NG, Jacques L, Haumann B. Efficacy and optimal dosing interval of the long-acting beta2 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period	Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean was derived by calculating the average area under curve, and then dividing by the relevant time interval. 24-hour serial measurements of FEV1 were performed on Day 7 of each of the 5 treatment periods (Visits 3, 5, 7, 9, and 11). Measurements were taken at pre-dose; 30 and 60 minutes; and 3, 5, 11, 12, 12.5, 13, 15, 17, 23, and 24 hours post-dose. Visits 3, 5, 7, 9, and 11 were overnight visits. Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed effects analysis of covariance (ANCOVA) model, with fixed effects for treatment, period, sex, and age. Participant was fitted as a random effect, and the period Baseline FEV1 measurement was 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)	No