NCT00999466

Brief Summary

AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis (hayfever). This study will be in two parts and will include 59 asthmatic patients in total. The first part will investigate the tolerability and safety of AZD8848 while the second part will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2009

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

October 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

January 26, 2016

Completed
Last Updated

February 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

October 20, 2009

Results QC Date

August 31, 2015

Last Update Submit

January 28, 2016

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (3)

  • FEV1, Late Asthmatic Response (LAR) - Pre-treatment

    Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

    Pre-treatment (Baseline measurement)

  • FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose

    FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

    1 week after last dose

  • FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose

    FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

    4 weeks after last dose

Secondary Outcomes (87)

  • FEV1, Early Asthmatic Response (EAR) - Pre-treatment

    Pre-treatment (Baseline measurement)

  • FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose

    1 week after last dose

  • FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose

    4 weeks after last dose

  • PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge

    Pre-treatment, pre allergen challenge

  • PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge

    Pre-treatment, post allergen challenge

  • +82 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

AZD8848 (30 μg PILOT part and 60 μg MAIN part)

Drug: AZD8848

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD8848DRUG

Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.

1
PlaceboDRUG

Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • FEV1 \> 70 % of predicted normal pre-bronchodilator
  • Documented history of asthma
  • Presence of allergic sensitivity

You may not qualify if:

  • Clinically relevant disease and/or abnormality (past or present), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
  • Symptomatic allergic rhinitis
  • Any clinical relevant abnormal findings in physical examination or assessment which may put the patient at risk because of participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Related Publications (1)

  • Leaker BR, Singh D, Lindgren S, Almqvist G, Eriksson L, Young B, O'Connor B. Effects of the Toll-like receptor 7 (TLR7) agonist, AZD8848, on allergen-induced responses in patients with mild asthma: a double-blind, randomised, parallel-group study. Respir Res. 2019 Dec 19;20(1):288. doi: 10.1186/s12931-019-1252-2.

    PMID: 31856838DERIVED

Related Links

MeSH Terms

Interventions

AZD8848

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Leif Eriksson, MD

    AstraZeneca R&D Lund

    STUDY DIRECTOR

  • Brian Leaker, MD

    Respiratory Clinical Trials

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
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 20, 2009

First Posted

October 21, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2011

Study Completion

December 1, 2011

Last Updated

February 26, 2016

Results First Posted

January 26, 2016

Record last verified: 2016-01

Locations

GB(2)