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

Study Overview
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Brief Summary
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The purpose of this study is to compare once and twice daily GW685698 in asthma

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: GW685698X


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GW685698X<br> | Drug: GW685698X<br>* Inhaled Corticosteroid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 |