A two-centre, randomised, double-blind, double-dummy, placebo-controlled, 3-period cross-over study to evaluate the effect of treatment with repeat doses of GW274150 on the allergen-induced late asthmatic response in subjects with mild asthma.
- Conditions
- Mild asthma
- Registration Number
- EUCTR2004-000576-13-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Males and females aged 18 to 55 years inclusive. Women must be of non-childbearing potential. Women will only be considered for inclusion if they have
documented proof of hysterectomy or tubal ligation, or meet the criteria for
menopause and have been amenorrhoeic for more than 1 year.
2. Documented history of bronchial asthma, first diagnosed at least 6 months prior to
the screening visit and currently being treated only with intermittent short-acting beta-agonist therapy by inhalation.
3. Pre-bronchodilator FEV1 >65% of predicted at screening.
4. Documented sensitivity to AMP with a provocative concentration of AMP resulting
in a 20% fall in FEV1 (PC20 AMP) of less than 100 mg/mL at screening.
5. Documented sensitivity to methacholine with a provocative concentration of
methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of <8 mg/mL or
provocative dose of methacholine =3.2 mg (PD20 methacholine) resulting in a 20%
fall in FEV1 at screening.
6. No history of smoking within 6 months of the start of the study, and with a total pack year history of =10 pack years.
7. Demonstration of a positive wheal and flare reaction (=3 mm relative to negative
control) to at least one allergen from a battery of allergens (including house dust
mite, grass pollen and cat dander) on skin prick testing at screening, or within 12
months of study start.
8. Screening allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of =20% from the post saline value, on at least one occasion, between 5 and
30 minutes after the final concentration of allergen. The late asthmatic response
must include a fall in FEV1 of =15% from the post saline value, on at least three
occasions, two of which must be consecutive, between 4 and 10 hours after the final
concentration of allergen.
Are the trial subjects under 18? no
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. 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, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).
2. Clinically significant abnormalities in safety laboratory analysis at screening.
3. Subject has known history of hypertension or is hypertensive at screening.
Hypertension at screening is defined as persistent systolic BP >140mmHg or
diastolic BP > 90mmHg.
4. Known hypersensitivity to Singulair.
5. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
6. History of life-threatening asthma, defined as an asthma episode that required
intubation and/or was associated with hypercapnoea, respiratory arrest and/or
hypoxic seizures.
7. Administration of oral, injectable or dermal steroids within 5 weeks or intranasal
and/or inhaled steroids within 1 week of the screening visit.
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