Clinical trial NCT01185080: Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848
Official title: A Double-blind, Placebo Controlled, Randomised, Parallel Group Phase IIa Study to Investigate the Efficacy, Tolerability, and Safety of Different Dosing Regimens of AZD8848 Administered Intranasally to Seasonal Allergic Rhinitis Patients Out of Pollen Season in a Nasal Allergen Challenge Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: AZD8848
allergic rhinitis
efficacy
tolerability
safety
nasal symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-08-19
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to investigate effect, tolerability and safety of different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis patients out of season in an allergen challenge model.

Detailed description: A double-blind, placebo controlled, randomised, parallel group phase IIa study to investigate the efficacy, tolerability, and safety of different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis patients out of pollen season in a nasal allergen challenge model

Eligibility criteria: Inclusion Criteria:

* Seasonal allergic rhinitis patients out of pollen season
* Have a history and presence 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:

* Symptomatic perennial allergic or non-allergic rhinitis
* Family history of autoimmune disease A history of asthma

Primary outcomes:
measure: Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
timeFrame: During 1st day to 7th day of Allergen challenge period.
measure: Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
timeFrame: During 4th day to 7th day of Allergen challenge period.
measure: Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
timeFrame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
measure: Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
timeFrame: During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.
measure: Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
timeFrame: During 1st day to 7th day of Allergen challenge period.
measure: Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
timeFrame: During 4th day to 7th day of Allergen challenge period.
measure: Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
timeFrame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
measure: of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
timeFrame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
Secondary outcomes:
measure: Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
timeFrame: Pre-dose on visit 2 (baseline)
measure: Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
timeFrame: Pre-dose on visit 11 (end of 3rd week of treatment)
measure: Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
timeFrame: Pre-dose on visit 2 (baseline)
measure: Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
timeFrame: Pre-dose on visit 11 (end of 3rd week of treatment)
measure: Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma
timeFrame: Baseline to 1st day of visit 15
measure: Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage
timeFrame: Baseline to 1st day of visit 15
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research Site
state: Malmohus Lan
city: Helsingborg
country: Sweden
facility: Research Site
Study officials:
affiliation: Lund University Hospital, Sweden
name: Lennart Greiff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Lund, Sweden
name: Sam Lindgren, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Greiff L, Ahlstrom-Emanuelsson C, Alenas M, Almqvist G, Andersson M, Cervin A, Dolata J, Lindgren S, Martensson A, Young B, Widegren H. Biological effects and clinical efficacy of a topical Toll-like receptor 7 agonist in seasonal allergic rhinitis: a parallel group controlled phase IIa study. Inflamm Res. 2015 Nov;64(11):903-15. doi: 10.1007/s00011-015-0873-2. Epub 2015 Sep 5.