NCT00770003CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments
Study Overview
Brief Summary
The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848 administered intranasally to seasonal allergic rhinitis patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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
Arms & Interventions
1
Experimental
Intervention: AZD8848 (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments
Time Frame: During the study
Nasal symptoms, peak nasal inspiratory flow
Time Frame: During the study
Secondary Outcomes
- Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow(During the study)
- Pharmacokinetics(During the study)
- Blood biomarkers and nasal lavage biomarkers(During the study)
Investigators
Study Sites (1)
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