A randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 500µg of GW799943X administered once-daily in the morning, 500µg of GW799943X administered once-daily in the evening, and 1000µg GW799943X administered once-daily in the morning compared with placebo and fluticasone propionate 250µg twice daily, all delivered by ROTADISK/DISKHALER for 28 days in subjects with persistent bronchial asthma symptomatic on low-dose ICS.
- Conditions
- Out-patients with persistent bronchial asthma, currently symptomatic on low dose inhaled corticosteroids.MedDRA version: 7.1Level: 4Classification code 10003553
- Registration Number
- EUCTR2004-005058-30-DE
- Lead Sponsor
- GlaxoSmithKline R&D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 650
1.Male and females aged 18 - 65 years inclusive on the day the subject gives consent to participate in the study.
A female is eligible to enter and participate in the study if she is of:
a.Non childbearing potential or
b.Child-bearing potential, has a negative pregnancy test (urine) at entry, and agrees to an acceptable contraceptive method when used consistently and correctly •
2.Documented clinical history of mild/moderate persistent asthma first diagnosed at least 6 months prior to Visit 1.
3.Currently receiving inhaled SABA for symptom relief.
4.Able and willing to give written informed consent to take part in the study.
5.Able to comply with all the study requirements.
6.A lung function of between 50-80% predicted pre-bronchodilator peak expiratory flow (PEF) at Visit 1.
7.Increase in PEF of = 15% 20 minutes after inhalation of 200-400µg salbutamol/albuterol at Visit 1.
At the end of the Run-In period, subjects must fulfil the following additional criteria from Daily Record Card recordings in order to enter the treatment period of the study.
1.Mean morning PEF (calculated from the last 7 consecutive days of the run-in period) of between 50% and 80% of their predicted normal value.
(ECCS predicted values will be used for subjects aged = 18 to 65 years [ECCS, 1993; Polgar, 1971])
2.Daily asthma symptom score (day-time and night-time) of = 1 on at least four of the last seven consecutive days of the run-in period and a total score of = 7 over the last 7 consecutive days.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.History of upper or lower respiratory tract infection and/or exacerbation of asthma within 4 weeks of Visit 1.
2.History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures.
3.A history of 2 or more asthma exacerbations requiring treatment with oral corticosteroids or requiring hospitalisation in the 6 months before Visit 1.
4.Past or present disease which, 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).
5.Known or suspected sensitivity to the constituents of ROTADISKs (e.g. lactose) or severe milk protein allergy.
6.Undergoing allergen desensitisation therapy.
7.Is a current smoker or has a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years).
8.Administration of inhaled or intranasal corticosteroids within 4 weeks of Visit 1 or systemic, oral or depot corticosteroids within 8 weeks of Visit 1.
9.Administration of anti-leukotrienes, including suppressors of leukotriene production and antagonists within 4 weeks of Visit 1.
10.Administration of combination therapy for asthma containing ß2-agonists and/or inhaled corticosteroids within 4 weeks of Visit 1.
11.Administration of known inhibitors of CYP 3A4 (e.g. ritonaivir, ketoconazole) within 4 weeks of Visit 1.
12.Administration of bronchodilators (theophyllines, slow release bronchodilators, oral ß2-agonists, long-acting-inhaled ß2-agonists, and anticholinergics) within 2 weeks of Visit 1.
13.Administration of ketotifen within 2 weeks of Visit 1.
14.Pregnant or lactating females
At the end of the Run-In period subjects must not meet any of the following additional criteria in order to enter the treatment period of the study.
1.Evidence of clinically significant abnormality, as judged by the investigator, in the haematological, biochemical or urinalysis screen at Visit 1.
2.Evidence of clinically significant abnormality, as judged by the investigator, in the 12-lead ECG at Visit 1.
3.Changes in asthma medication (excluding rescue salbutamol/albuterol provided at Visit 1).
4.Occurrence of an upper or lower respiratory tract infection during the run-in period.
5.Exacerbation of asthma during the run-in period. (An exacerbation of asthma is defined as any clinical worsening of asthma that requires treatment with anything other than rescue salbutamol/albuterol.)
6.Non-compliance with completion of the DRC. (Subjects must have completed PEF and symptom data for at least 5 of the last 7 consecutive days of the run-in period.)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method