To investigate wether or not the study drug is still working and safe after 6 days of daily dosing.The study drug will be adminstered to asthmatics.

• Conditions: Allergic asthma; MedDRA version: 13.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-001698-22-NL
• Lead Sponsor: Verona Pharma plc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

•Healthy males between 18 and 55 years of age at screening (both inclusive)
•Clinically stable mild to moderate asthma, defined as
o Documented history of mild to moderate persistent asthma, first diagnosed by an MD at least 6 months prior to the screening visit and currently controlled by beta-agonists on an as needed” basis only
o Clinically stable asthma, i.e. stable asthma symptoms and baseline prebronchodilator FEV1 values within 10% (i.e. study day 1 compared to screening) (preferably measured at the same time of day ±3 h); stable use of as needed” Short-Acting Beta2 Agonist (SABA) but not on controller medication (see exclusion criteria)
o Pre-bronchodilator FEV1 =70% of predicted
o Documented bronchial hyper-responsiveness to inhaled Methacholine (MCh) with a PC20Meth of =8 mg/mL at screening
o No recent respiratory tract infections (within 3 weeks of screening and during study)
o Documented reversibility in lung function defined as = 12% or = 200 mL increase in FEV1 compared to pre-salbutamol 200 microgram value.
• No clinically relevant history of cardiovascular (including arrhythmias) disease; no active hyperthyroidism
• No clinically relevant history of chronic or malignant diseases (except for in situ basalioma)
• Body mass index (BMI) between 18 and 33 kg/m2 (both inclusive)
• Systolic blood pressure (SBP) 100-155 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and heart rate (HR) 45-90 beats per min (inclusive), measured on the arm with the highest blood pressure after resting for 5 min in the supine position
• No clinically significant findings on physical examination other than allergy and mild to moderate persistent asthma
• 12-lead ECG without clinically relevant abnormalities
• Non-smokers or ex-smokers (stopped for at least 6 months before screening, and <10 pack-years)
• No history of anaphylaxis, or of severe food or medication allergy
• Haematology, clinical chemistry and urinalysis test results not deviating from the normal range to a clinically relevant extent as deemed by the investigator
• Negative results from urine drug and cotinine screens (for nicotine use)
• Negative screening for Hepatitis B, Hepatitis C and HIV
• Documented allergy by a standardized Skin Prick Test (SPT): i.e. a positive wheal response to one or more of the common airborne allergens: Grass or tree Pollen, House Dust Mite, D. Farinae, cat, dog, or horse-dander, Aspergillus Fumigatus, A. Alternata, Artemisia Vulgaris (in the past 1 year)
• Steroid-naïve, or not on inhaled/nasal corticosteroids for at least one month and 8 weeks of systemic therapy before the study
• No use of anti-IgE (omalizumab) in the past 6 months
• No systemic or aerosol use of the following: leukotriene receptor antagonists (LTRA), theophylline, long acting beta agonists (LABA), or antihistamine such as H1 receptor antagonist for 2 weeks before the study
• No nasal medications (steroids, antihistamines, cromones) for one month (for nasal steroids), or 2 weeks for other medications; xylomethazoline (1 week); nasal NaCl 0.9% allowed
• Ability to communicate well with the investigator and to understand and comply with the requirements of the study
• Signed informed consent
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 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Numbe

Exclusion Criteria

• Desensitization therapy in the past 5 years
• Severe exacerbation requiring hospital evaluation and/or admission in the past 2 years
• Unstable/uncontrolled disease within 3 weeks of participation in the study
• History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug
• Treatment with another investigational drug within 3 months prior to screening
• Known hypersensitivity to any excipients of the drug formulations
• History or clinical evidence of alcoholism within the 3-year period prior to screening (i.e. regular use of more than 21 units of alcohol/week for males and more than 14 units/week for females)
• Excessive caffeine consumption, defined as > 8 cups/per day at screening – unable to discontinue caffeine consumption for at least 8 h before and during the testing
• History or any other clinical condition, judged to be a contraindication for participation in the study as judged by the PI
• Loss of 250 mL or more of blood within 3 months prior to screening
• Any abnormalities on lab or urine results outside the normal range, deemed clinically significant by the investigator (and with written consent of the sponsor)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified