Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma

Asthma Clinical Trial

Official title:

A Multi-Centre, Randomized, Double Blind Cross-over Study to Assess the Non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766090
• Other study ID #: 112202
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2008
• Last updated: August 4, 2014
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare once and twice daily GW685698 in asthma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Key Inclusion Criteria:

• Clinical diagnosis of Asthma

• Reversibility = 12% and =200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol

• FEV1 between 40-85% predicted

• Currently on short acting beta2 agonist therapy

Key Exclusion Criteria:

• History of life threatening asthma

• Respiratory Infection or oropharyngeal candidiasis

• Asthma exacerbation

• Uncontrolled disease or clinical abnormality

• Allergies

• Taking another Investigational medications or other prohibited medications

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:
• GW685698X
Inhaled Corticosteroid

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Bethesda	Maryland
United States	GSK Investigational Site	Boerne	Texas
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Cocoa	Florida
United States	GSK Investigational Site	Columbia	Missouri
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rolla	Missouri
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Woodcock A, Bleecker ER, Busse WW, Lötvall J, Snowise NG, Frith L, Jacques L, Haumann B, Bateman ED. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respir Res. 2011 Dec 21;12:160. doi: 10.1186/1465-9921-12-160. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period	Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.	Day 28 of the relevant treatment period (up to Study Day 112)	No
Secondary	Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods	An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.	From the first dose of the study medication up to Week 16/Early Withdrawal	No
Secondary	24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period	A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.	Day 28 of the relevant treatment period (up to Study Day 112)	No
Secondary	Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period	Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.	Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)	No
Secondary	Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.	Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)	No
Secondary	Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period	Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.	Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)	No
Secondary	Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods	Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.	From the first dose of the study medication up to Week 16/Early Withdrawal	No