A randomised, double-blind, placebo-controlled, 3-period cross-over study to evaluate the effect of two doses of GSK2190915 on the allergen-induced early asthmatic response in subjects with mild asthma
- Conditions
- Mild asthmaMedDRA version: 9.1Level: LLTClassification code 10001705Term: Allergic asthma
- Registration Number
- EUCTR2008-005205-19-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Males and females aged 18 to 55 years inclusive.
2. Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
3. Female subjects must be of non childbearing potential.
4. Male subjects must agree to use one of the contraception methods listed in
Section 8.1 of the protocol.
5. 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.
6. Pre-bronchodilator FEV1 >70% of predicted at screening.
7. Subjects who are current non-smokers who have not used any tobacco products
in the 6-month period preceding the screening visit.
8. Demonstration of a positive wheal and flare reaction (> 3 mm relative to negative
control) to at least one allergen from a battery of allergens on skin prick testing.
9. Methacholine challenge PC20 < 8 mg/mL at screening or previous AMP, histamine
or methacholine challenge that confirms the diagnosis of asthma.
10. Screening allergen challenge demonstrates that the subject experiences an
early asthmatic response.
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 or medical monitor,
may affect the outcome of this study.
2. Clinically significant abnormalities in safety laboratory analysis at screening.
3. Subject has known history of hypertension or is hypertensive at screening.
4. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to
the first dose of study medication.
5. 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.
6. Symptomatic with hay fever at screening or predicted to have symptomatic
hayfever during the time of study.
7. Administration of oral or injectable steroids within 5 weeks of screening or
intranasal and/or inhaled steroids within 4 weeks of the screening visit.
8. Unable to abstain from other medications including non-steroidal anti-
inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-
asthma, anti-rhinitis or hay fever medication.
9. If, after 2 concurrent administrations of saline during the allergen challenge at
screening the subjects still have a fall in FEV1 of greater than 10%.
10.The subject has participated in a study with a new molecular entity during the
previous 3 months or has participated in 4 or more clinical studies in the previous
12 months prior to the first dosing day.
11.History of being unable to tolerate or complete methacholine and/or allergen
challenge tests.
12.The subject has a screening QTc value of >450msec, PR interval outside the
range 120 to 220msec or an ECG that is not suitable for QT measurements.
13.The subject has tested positive for hepatitis C antibody or hepatitis B surface
antigen.
14.The subject has tested positive for HIV antibodies.
15.The subject has a positive pre-study urine cotinine/ breath carbon monoxide test
or urine drug or urine or breath alcohol screen.
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