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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Asthma
• Intervention / Treatment: Drug: ADC3680B oral; Drug: Placebo oral

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT9 6AD
  • Manchester, United Kingdom, M23 9QZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADC3680B oral	Drug: ADC3680B oral; Once daily for 28 days
Placebo Comparator: Placebo oral	Drug: Placebo oral; Once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pulmagen Therapeutics

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): February 20, 2012
• Last Update Submitted That Met QC Criteria: February 17, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ADC3680-04