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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00770003
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : August 14, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: AZD8848 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2008
Primary Completion Date : March 2009
Study Completion Date : February 2010

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments [ Time Frame: During the study ]
  2. Nasal symptoms, peak nasal inspiratory flow [ Time Frame: During the study ]

Secondary Outcome Measures :
  1. Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow [ Time Frame: During the study ]
  2. Blood biomarkers and nasal lavage biomarkers [ Time Frame: During the study ]
  3. Pharmacokinetics [ Time Frame: During the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: August 14, 2015
Last Verified: August 2015

Keywords provided by AstraZeneca:
allergic rhinitis
nasal symptoms

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action