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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: October 8, 2008
Last updated: August 13, 2015
Last verified: August 2015
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

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.


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

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 identifier: NCT00770003

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00770003     History of Changes
Other Study ID Numbers: D0540C00003 
Study First Received: October 8, 2008
Last Updated: August 13, 2015
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
allergic rhinitis
nasal symptoms

Additional relevant MeSH terms:
Rhinitis, Allergic
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on May 26, 2016