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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pulmagen Therapeutics
ClinicalTrials.gov Identifier:
NCT01448954
First received: September 26, 2011
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Atopic Asthma
Drug: ADC3680B oral
Drug: Placebo oral
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pulmagen Therapeutics:

Primary Outcome Measures:
  • Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability [ Time Frame: Baseline to Day 35 ] [ Designated as safety issue: Yes ]
  • Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety [ Time Frame: Baseline to Day 35 ] [ Designated as safety issue: Yes ]
  • Evaluation of the change in vital signs as a measure of safety [ Time Frame: Baseline to Day 35 ] [ Designated as safety issue: Yes ]
  • Evaluation of the change in Pulmonary function as a measure of safety and tolerability [ Time Frame: Baseline to Day 35 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination of concentrations of ADC3680B in plasma [ Time Frame: Days 1-2 and Days 28-30 ] [ Designated as safety issue: No ]
  • Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADC3680B oral Drug: ADC3680B oral
Once daily for 28 days
Placebo Comparator: Placebo oral Drug: Placebo oral
Once daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448954

Locations
United Kingdom
Belfast, United Kingdom, BT9 6AD
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Pulmagen Therapeutics
  More Information

No publications provided

Responsible Party: Pulmagen Therapeutics
ClinicalTrials.gov Identifier: NCT01448954     History of Changes
Other Study ID Numbers: ADC3680-04
Study First Received: September 26, 2011
Last Updated: February 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014