A Combined Clinical Phase I/IIa Study of the Safety and Efficacy of Nebulized RPL554 in Healthy Subjects, Allergic Asthmatics, and Allergic Rhinitics

Completed

Conditions: bronchial asthma
10038716

Registration Number: NL-OMON32512

Lead Sponsor: Verona Pharma plc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 62

Inclusion Criteria

Male volunteers: healthy, non-smokers
Female volunteers: healthy, post-menopausal, non-smokers
Asthmatic patients: history of allergic asthma for at least 6 months, stable allergic asthma, Pre-bronchodilator FEV1 >=70% of predicted, documented bronchial hyper-responsiveness to inhaled Methacholine bromide (MCh) with a PC20MCh of <=4 mg/mL, documented allergy by a standardized Skin Prick Test (SPT)
Patients with allergic rhinitis: Documented allergy by a standardized Skin Prick Test (SPT), History of allergic rhinitis for at least 6 months, clinically stable allergic rhinitis

Exclusion Criteria

Volunteers: clinical significant abonormalities (females: potential fertile)
Asthmatic patients: unstable asthma, recent (<4 weeks) treatment with inhaled corticosteroids or with systemic corticosteriods (within 8 weeks), recent (within 4 weeks) or actual airways viral infection, clinical significant abonormalities (females potential fertile).
Rhinitic patients: unstable allergic rhinitis, history of nasal surgery, evidence of nasal polyps, clinical significant abonrmalities (females potential fertile)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the safety of nebulized RPL554 in healthy subjects, allergic<br /><br>asthmatics and allergic rhinitics using standard safety measures.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate whether nebulized RPL554 possesses:<br /><br>-Bronchodilator (increase in FEV1) and bronchoprotective activity (increase in<br /><br>PC20 to inhaled methacholine), respectively, in patients with clinically stable<br /><br>allergic asthma, not on controller medications and without regular use of<br /><br>bronchodilators.<br /><br>-Anti-inflammatory effects in subjects with allergic rhinitis not on controller<br /><br>therapy following a standardized nasal challenge with a relevant allergen<br /><br>(inhibition of the allergen-induced nasal eosinophilia in nasal brushes).<br /><br>-To investigate RPL554s effect on the following exploratory measures:<br /><br>-Nasal composite symptom scores post-allergen (RPL554 versus placebo)<br /><br>-To investigate RPL554s pharmacokinetics in plasma and urine.</p><br>