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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770003
• Other study ID #: D0540C00003
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2008
• Last updated: August 13, 2015
• Start date: September 2008
• Est. completion date: February 2010

Study information

• Verified date: August 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• AZD8848
nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month
• Placebo
nasal spray solution. Once weekly intranasal administrations for one month.

Locations

Country	Name	City	State
Sweden	Research Site	Helsingborg
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments		During the study	Yes
Primary	Nasal symptoms, peak nasal inspiratory flow		During the study	Yes
Secondary	Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow		During the study	No
Secondary	Blood biomarkers and nasal lavage biomarkers		During the study	No
Secondary	Pharmacokinetics		During the study	No

External Links

•   CSR Synopsis