A Study of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.

Official Title
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A Randomised, Double-blind, Double Dummy, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening All Administered by Inhalation Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.

Conditions
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Asthma

Intervention / Treatment
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* Drug: GW685698X (fluticasone furoate) 100mcg Morning
* Drug: GW685698X (fluticasone furoate) 100mcg Evening
* Drug: GW685698X (fluticasone furoate) 250mcg Evening
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients aged between 16- 65 years. Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods Documented clinical history of persistent asthma first diagnosed at least 6 months prior to Visit 1 Currently receiving inhaled short-acting beta-2 agonists for symptom relief A lung function of between 50 to 90% predicted (PEF) Increase in PEF of at least15%, 20 minutes after inhalation of 400mcg salbutamol Exclusion Criteria: History of respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1 History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures. A history of two or more asthma exacerbations requiring treatment with oral corticosteroids or hospitalisation in the 6 months before Visit 1. Past or present disease that, as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematologic disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis and bronchopulmonary dysplasia). Known or suspected sensitivity to corticosteroids, VENTOLIN, or the constituents of ROTADISKS (e.g., lactose). Undergoing allergen desensitisation therapy. Neurological or psychiatric disease or history of drug or alcohol abuse that would interfere with the subject's proper completion of the protocol requirements. Is a current smoker or has a smoking history of 10 pack years or more (e.g., 20 cigarettes/day for 10 years). Note: Current smoker is defined as currently smoking or stopped smoking within 6 months of screening visit.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GW685698X (fluticasone furoate) 100mcg Morning<br> | Drug: GW685698X (fluticasone furoate) 100mcg Morning<br>* GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days<br>|
| Experimental: GW685698X (fluticasone furoate) 100mcg Evening<br> | Drug: GW685698X (fluticasone furoate) 100mcg Evening<br>* GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days<br>|
| Experimental: GW685698X (fluticasone furoate) 250mcg Evening<br> | Drug: GW685698X (fluticasone furoate) 250mcg Evening<br>* GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days<br>|
| Placebo Comparator: Placebo<br> | Drug: GW685698X (fluticasone furoate) 100mcg Morning<br>* GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days<br>Drug: GW685698X (fluticasone furoate) 100mcg Evening<br>* GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days<br>Drug: GW685698X (fluticasone furoate) 250mcg Evening<br>* GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days<br>Drug: Placebo<br>* Placebo inhaled twice daily (morning and evening) for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak expiratory flow (PEF) | Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak expiratory flow (PEF) | Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 250mcg once daily compared with GW685698X 100mcg once daily both administered in the evening by inhalation via DISKHALER. | 28 days | 
| PEF | Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning, 100mcg once daily in the evening, or GW685698X 250mcg once daily in the evening, compared with placebo | 28 days | 
| Clinic lung function | Change from baseline in pre bronchodilator clinic lung function (forced expiratory volume in 1 second [FEV1] and PEF) after 28 days of treatment with GW685698X 250mcg once daily in the evening compared with GW685698X 100mcg once daily in the evening | 28 days |