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Completed

NCT Number: NCT01448954

A Study to Evaluate 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.

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Key information

Conditions

Atopic Asthma

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Belfast, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADC3680B oral

Drug

Once daily for 28 days

Placebo Oral

Drug

Once daily for 28 days

Primary outcomes

  1. Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability

    Time frame: Baseline to Day 35

  2. Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety

    Time frame: Baseline to Day 35

  3. Evaluation of the change in vital signs as a measure of safety

    Time frame: Baseline to Day 35

  4. Evaluation of the change in Pulmonary function as a measure of safety and tolerability

    Time frame: Baseline to Day 35

  5. Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability

    Time frame: Baseline to Day 28

Secondary outcomes

  1. Determination of concentrations of ADC3680B in plasma

    Time frame: Days 1-2 and Days 28-30

  2. Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood

    Time frame: Day 1 and Day 28

Sponsors and collaborators

Lead sponsor

Pulmagen Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2011
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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