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Completed

NCT Number: NCT00770003

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

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

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Helsingborg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8848

Drug

nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month

Placebo

Drug

nasal spray solution. Once weekly intranasal administrations for one month.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 9, 2008
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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