A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma
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
1 other identifier
interventional
36
1 country
2
Brief Summary
This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2011
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 26, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 20, 2012
February 1, 2012
5 months
September 26, 2011
February 17, 2012
Conditions
Outcome Measures
Primary Outcomes (5)
Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability
Baseline to Day 35
Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety
Baseline to Day 35
Evaluation of the change in vital signs as a measure of safety
Baseline to Day 35
Evaluation of the change in Pulmonary function as a measure of safety and tolerability
Baseline to Day 35
Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability
Baseline to Day 28
Secondary Outcomes (2)
Determination of concentrations of ADC3680B in plasma
Days 1-2 and Days 28-30
Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood
Day 1 and Day 28
Study Arms (2)
ADC3680B oral
EXPERIMENTALPlacebo oral
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Partially controlled mild-moderate atopic asthma
- Receiving inhaled corticosteroids
- Non-smoker or former smoker
- Males and females aged 18 to 55 years inclusive
- If female, must be of non-childbearing potential
You may not qualify if:
- History of acute severe asthma attacks
- History of COPD
- Other serious respiratory or other medical condition which may interfere with the outcome of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Belfast, BT9 6AD, United Kingdom
Unknown Facility
Manchester, M23 9QZ, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2011
First Posted
October 7, 2011
Study Start
September 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 20, 2012
Record last verified: 2012-02