A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma

Atopic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448954
• Other study ID #: ADC3680-04
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2011
• Last updated: February 17, 2012
• Start date: September 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Pulmagen Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Atopic Asthma

Intervention

Drug:
• ADC3680B oral
Once daily for 28 days
• Placebo oral
Once daily for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pulmagen Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability		Baseline to Day 35	Yes
Primary	Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety		Baseline to Day 35	Yes
Primary	Evaluation of the change in vital signs as a measure of safety		Baseline to Day 35	Yes
Primary	Evaluation of the change in Pulmonary function as a measure of safety and tolerability		Baseline to Day 35	Yes
Primary	Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability		Baseline to Day 28	Yes
Secondary	Determination of concentrations of ADC3680B in plasma		Days 1-2 and Days 28-30	No
Secondary	Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood		Day 1 and Day 28	No