NCT00770003

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

October 8, 2008

Last Update Submit

August 13, 2015

Conditions

Allergic Rhinitis

Keywords

patientsallergic rhinitistolerabilitysafetynasal symptoms

Outcome Measures

Primary Outcomes (2)

  • Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments

    During the study

  • Nasal symptoms, peak nasal inspiratory flow

    During the study

Secondary Outcomes (3)

  • Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow

    During the study

  • Blood biomarkers and nasal lavage biomarkers

    During the study

  • Pharmacokinetics

    During the study

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD8848

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD8848DRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis
  • Symptomatic perennial allergic or non-allergic rhinitis
  • A history of asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Helsingborg, Sweden

Location

Research Site

Lund, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 26342289DERIVED

  • Greiff L, Cervin A, Ahlstrom-Emanuelsson C, Almqvist G, Andersson M, Dolata J, Eriksson L, Hogestatt E, Kallen A, Norlen P, Sjolin IL, Widegren H. Repeated intranasal TLR7 stimulation reduces allergen responsiveness in allergic rhinitis. Respir Res. 2012 Jun 22;13(1):53. doi: 10.1186/1465-9921-13-53.

    PMID: 22726593DERIVED

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

AZD8848

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lennart Greiff, MD PhD

    Lund University Hospital

    PRINCIPAL INVESTIGATOR

  • Leif T Eriksson, MD, PhD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

February 1, 2010

Last Updated

August 14, 2015

Record last verified: 2015-08

Locations

SE(2)