Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00770003
First received: October 8, 2008
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848 administered intranasally to seasonal allergic rhinitis patients.


Condition Intervention Phase
Allergic Rhinitis
Drug: AZD8848
Drug: Placebo
Phase 1

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, Randomized, Parallel Group Study to Investigate the Tolerability, Safety, Pharmacodynamics and Pharmacokinetics of Repeated Weekly Doses of AZD8848 Administered Intranasally to Seasonal Allergic Rhinitis Patients

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
  • Nasal symptoms, peak nasal inspiratory flow [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Blood biomarkers and nasal lavage biomarkers [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: During the study ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD8848
nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month
Placebo Comparator: 2 Drug: Placebo
nasal spray solution. Once weekly intranasal administrations for one month.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a history of birch and/ or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test)
  • Patients with need of treatment for their nasal symptoms during the pollen season

Exclusion Criteria:

  • Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis
  • Symptomatic perennial allergic or non-allergic rhinitis
  • A history of asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770003

Locations
Sweden
Research Site
Helsingborg, Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Lennart Greiff, MD PhD Lund University Hospital
Study Director: Leif T Eriksson, MD, PhD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leif T Eriksson, MD, PhD, Medical Science Director, RITA EPT2, AstraZeneca Research and Development
ClinicalTrials.gov Identifier: NCT00770003     History of Changes
Other Study ID Numbers: D0540C00003
Study First Received: October 8, 2008
Last Updated: November 30, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
patients
allergic rhinitis
tolerability
safety
nasal symptoms

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014