A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Phase II Study to Assess the Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects with Partly Controlled Atopic Asthma

• Conditions: Asthma; MedDRA version: 14.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-002816-97-GB
• Lead Sponsor: Pulmagen Therapeutics LLP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-17
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Partially controlled atopic mild-moderate subjects with asthma
2. Receiving inhaled corticosteriods
3. Non-smoker or former smoker
4. Males and females aged 18 to 55 years inclusive
5. If female, must be of non-childbearing potential
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 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of acute severe asthma attacks
2. History of COPD
3. Other serious respiratory or other medical condition which may interfere with the outcome of the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the safety and tolerability of ADC3680B over 28 days treatment in partly controlled asthmatics;Secondary Objective: To characterise the multiple dose pharmacokinetics of ADC3680B following oral administration. Additionally, the effect of ADC3680B on exhaled nitric oxide and selected biomarkers of inflammation will be explored.;Primary end point(s): Evaluation of: Adverse events; medication use; vital signs and ECG; laboratory safety tests; spirometry and asthma symptoms (Asthma Control Questionnaire).;Timepoint(s) of evaluation of this end point: From Pre-dose and up to 7 days after IMP administration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pharmacokinetics after single and multiple dose administration. Exhaled nitric oxide and selected biomarkers of inflammation will be assessed.;Timepoint(s) of evaluation of this end point: At the study start for a period of 24 hours and at study end for a period of 48 hours