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The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00999466
First received: October 20, 2009
Last updated: December 21, 2011
Last verified: December 2011
History of Changes
  Purpose

AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis (hayfever). This study will be in two parts and will include 59 asthmatic patients in total. The first part will investigate the tolerability and safety of AZD8848 while the second part will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the drug.


Condition Intervention Phase
Allergic Asthma
 Drug: AZD8848
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomised, Parallel Group, Phase IIa Study to Investigate the Efficacy, Tolerability and Safety of 8 Doses of AZD8848 Administered Intranasally Once Weekly in Mild to Moderate Allergic Asthma Subjects Challenged With an Inhaled Allergen.

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • FEV1, Late Asthmatic Response (LAR) [ Time Frame: Measured 1 week and 4 weeks after last dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1, Early Asthmatic Response (EAR) [ Time Frame: Measured. 1 week and 4 weeks after last dose. ] [ Designated as safety issue: No ]
  • PC20 Methacholine Challenge - Bronchial Hyperreactivity measured by FEV1 [ Time Frame: Measured at 2 occasions pre-treatment (within 8 weeks of randomisation) and at 4 occasions post treatment (2-3 days before and 1 day +/- 6 hours after both allergen challenges). ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines - Sputum Biomarkers. [ Time Frame: Measured at 2 occasions pre-treatment (within 8 weeks of randomisation) and at 4 occasions post treatment (2-3 days before and 1 day +/- 6 hours after both allergen challenges). ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD8848 (30 μg PILOT part and 60 μg MAIN part)
 Drug: AZD8848
Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.
Placebo Comparator: 2
Placebo
 Drug: Placebo
Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.

  Eligibility

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

Inclusion Criteria:

  • FEV1 > 70 % of predicted normal pre-bronchodilator
  • Documented history of asthma
  • Presence of allergic sensitivity

Exclusion Criteria:

  • Clinically relevant disease and/or abnormality (past or present), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
  • Symptomatic allergic rhinitis
  • Any clinical relevant abnormal findings in physical examination or assessment which may put the patient at risk because of participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999466

Locations
United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Leif Eriksson, MD AstraZeneca R&D Lund
Principal Investigator: Brian Leaker, MD Respiratory Clinical Trials
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00999466     History of Changes
Other Study ID Numbers: D0540C00004
Study First Received: October 20, 2009
Last Updated: December 21, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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 May 19, 2013