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.

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: GW685698X (fluticasone furoate) 100mcg Morning; Drug: GW685698X (fluticasone furoate) 100mcg Evening; Drug: GW685698X (fluticasone furoate) 250mcg Evening; Drug: Placebo

• Registration Number: NCT01499446
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-26
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 669

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GW685698X (fluticasone furoate) 100mcg Morning	GW685698X (fluticasone furoate) 100mcg Morning	-
GW685698X (fluticasone furoate) 100mcg Evening	GW685698X (fluticasone furoate) 100mcg Evening	-
GW685698X (fluticasone furoate) 250mcg Evening	GW685698X (fluticasone furoate) 250mcg Evening	-
Placebo	GW685698X (fluticasone furoate) 100mcg Morning	-
Placebo	GW685698X (fluticasone furoate) 100mcg Evening	-
Placebo	GW685698X (fluticasone furoate) 250mcg Evening	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Peak expiratory flow (PEF)	28 days	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.

Secondary Outcome Measures

Name	Time	Method
Peak expiratory flow (PEF)	28 days	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.
PEF	28 days	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
Clinic lung function	28 days	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

Trial Locations

Locations (1)

GSK Investigational Site; 🇿🇦 Cape Town, South Africa