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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: GW685698X

• Registration Number: NCT00766090
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2010-02-05
• Disposition First Submitted QC: 2010-02-05
• Disposition First Posted: 2010-02-10
• Results First Submitted: 2013-06-06
• Results First Submitted QC: 2013-06-06
• Results First Posted: 2013-08-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GW685698X	GW685698X	-

Primary Outcome Measures

Name	Time	Method
Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period	Day 28 of the relevant treatment period (up to Study Day 112)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period	Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)	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.
24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period	Day 28 of the relevant treatment period (up to Study Day 112)	A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period	Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)	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.
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods	From the first dose of the study medication up to Week 16/Early Withdrawal	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.
Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period	Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)	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.
Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods	From the first dose of the study medication up to Week 16/Early Withdrawal	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Waco, Texas, United States