Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01185080
First received: August 11, 2010
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Drug: AZD8848
Drug: Placebo
Drug: AZD8848 and placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Mean of Reflective (-10 min) Total Nasal Symptom Score (TNSS) [ Time Frame: Days 1-7 (visit 15) ] [ Designated as safety issue: No ]

    The TNSS symptoms are:

    • runny nose,
    • blocked nose
    • maximum score of nasal itching or sneezing using the following scale (i.e. TNSS can range from 0 (good) to 9 (bad))
    • 0 = Absence of symptoms: no signs or symptoms evident
    • 1 = Mild symptoms: signs or symptoms clearly present, but minimal awareness, easily tolerated
    • 2 = Moderate symptoms: definite awareness of signs or symptoms that are bothersome but tolerable
    • 3 = Severe symptoms: signs or symptoms that are hard to tolerate, cause interference with activities of daily living and/or sleeping

  • Mean of Reflective (-10 min) Total Nasal Symptom Score (TNSS) [ Time Frame: Days 4-7 (visit 15) ] [ Designated as safety issue: No ]
  • Mean of morning measurements of Reflective (-12 hrs) Total Nasal Symptom Score (TNSS) [ Time Frame: Days 2-8 (visit 15) ] [ Designated as safety issue: No ]
  • Mean of evening measurements of Reflective (-12 hrs) Total Nasal Symptom Score (TNSS) [ Time Frame: Days 1-7 (visit 15) ] [ Designated as safety issue: No ]
  • Mean of Peak Nasal Inspiratory Flow (PNIF) (-10 min) [ Time Frame: Days 1-7 (visit 15) ] [ Designated as safety issue: No ]
    Adjusted for baseline (pre-dose visit 2). PNIF will be recorded immediately after TNSS scoring, according to local routines at the clinic. Briefly, the patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded, along with the date and time of collection.

  • Mean of Peak Nasal Inspiratory Flow (PNIF) (-10 min) [ Time Frame: Days 4-7 (visit 15) ] [ Designated as safety issue: No ]
    Adjusted for baseline (pre-dose visit 2)

  • Mean of morning measurements of Peak Nasal Inspiratory Flow (PNIF) (-12 hrs) [ Time Frame: Days 2-8 (visit 15) ] [ Designated as safety issue: No ]
    Adjusted for baseline (pre-dose visit 2)

  • Mean of evening measurements of Peak Nasal Inspiratory Flow (PNIF) (-12 hrs) [ Time Frame: Days 1-7 (visit 15) ] [ Designated as safety issue: No ]
    Adjusted for baseline (pre-dose visit 2)


Secondary Outcome Measures:
  • Instantaneous Total Nasal Symptom Score (TNSS) [ Time Frame: week 1 (pre-dose visit 2) ] [ Designated as safety issue: No ]
  • Instantaneous Total Nasal Symptom Score (TNSS) [ Time Frame: week 4 (pre-dose visit 11) ] [ Designated as safety issue: No ]
  • Instantaneous Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: week 1 (pre-dose visit 2) ] [ Designated as safety issue: No ]
  • Instantaneous Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: week 4 (pre-dose visit 11) ] [ Designated as safety issue: No ]
  • Change from baseline of C-X-C motif chemokine 10 (CXCL10) in blood [ Time Frame: Baseline (pre-dose visit 2) and day 1 of visit 15 ] [ Designated as safety issue: No ]
  • Change from baseline of C-X-C motif chemokine 10 (CXCL10) in nasal lavage [ Time Frame: Baseline (pre-dose visit 2) and day 1 of visit 15 ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. AZD8848
20 μg AZD8848 three times weekly
Drug: AZD8848
Nasal spray solution, intranasal, three times weekly for one month
Placebo Comparator: 2. Placebo
Placebo three times weekly
Drug: Placebo
Nasal spray solution, intranasal, three times weekly for one month
Experimental: 3. AZD8848 and placebo
60 μg AZD8848 once weekly and placebo twice weekly
Drug: AZD8848 and placebo
Nasal spray solution, intranasal, three times weekly for one month

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185080

Locations
Sweden
Research Site
Lund, Malmohus Lan, Sweden
Research Site
Helsingborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Lennart Greiff, MD, PhD Lund University Hospital, Sweden
Study Director: Sam Lindgren, MD, PhD AstraZeneca R&D Lund, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01185080     History of Changes
Other Study ID Numbers: D0540C00014, 2010-020747-13
Study First Received: August 11, 2010
Last Updated: March 2, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
AZD8848
allergic rhinitis
efficacy
tolerability
safety
nasal symptoms

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 16, 2014