Allergic AsthmaPhase 2NCT00999466

The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen

A Phase 2 study testing AZD8848 in people with Allergic Asthma, run by AstraZeneca at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Allergic Asthma
What is being tested?: AZD8848
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 2 sitesUnited Kingdom
Study dates: Oct 2009to Dec 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Research Site
London
Research Site
Manchester

Other trials in United Kingdom

About this study

Official title: A Double-blind, Placebo-controlled, Randomised, Parallel Group, Phase IIa Study to Investigate the Efficacy, Tolerability and Safety of 8 Doses of AZD8848 Administered Intranasally Once Weekly in Mild to Moderate Allergic Asthma Subjects Challenged With an Inhaled Allergen.

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.

Conditions: Allergic Asthma
Being tested: AZD8848, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD8848Drug
Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.
PlaceboDrug
Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.

Study groups in NCT00999466
Study group	Role	What they receive
1	Experimental	AZD8848 (30 μg PILOT part and 60 μg MAIN part) Receives: Drug: AZD8848
2	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 4 weeks after last dose

Secondary outcomes (87)

FEV1, Early Asthmatic Response (EAR) - Pre-treatment
FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Measured: Pre-treatment (Baseline measurement)
FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose
FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Measured: 1 week after last dose
FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose
FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Measured: 4 weeks after last dose
PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Measured: Pre-treatment, pre allergen challenge
PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Measured: Pre-treatment, post allergen challenge
PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Measured: 1 week after last dose, pre allergen challenge
PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Measured: 1 week after last dose, post allergen challenge
PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Measured: 4 weeks after last dose, pre allergen challenge
PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge
Measured: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge
Measured: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge
Measured: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge
Measured: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge
Measured: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge
Measured: 4 weeks after last dose, post allergen challenge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Dec 2011

First posted21 Oct 2009 (estimated)
Study startOct 2009
Primary completionFeb 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Allergic AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00999466
Sponsor's protocol ID: D0540C00004
Status last verified: Jan 2016
First submitted: 20 Oct 2009
Last updated: 26 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 31856838

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma

All Allergic Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomised, Parallel Group, Phase IIa Study to Investigate the Efficacy, Tolerability and Safety of 8 Doses of AZD8848 Administered Intranasally Once Weekly in Mild to Moderate Allergic Asthma Subjects Challenged With an Inhaled Allergen.
ClinicalTrials.gov ID: NCT00999466
Acronym / sponsor ID: D0540C00004
Conditions: Allergic Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Feb 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 21 Oct 2009 (estimated)
Results: Posted 26 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: AZD8848AZD8848 (30 μg PILOT part and 60 μg MAIN part)
2	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD8848Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.	Drug	1
PlaceboNasal spray, solution. Once weekly for 7 weeks, 8 doses in total.	Drug	2

Primary outcome

FEV1, Late Asthmatic Response (LAR) - Pre-treatment
Time frame: Pre-treatment (Baseline measurement)
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.
FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose
Time frame: 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.
FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose
Time frame: 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.

87 secondary outcomes

FEV1, Early Asthmatic Response (EAR) - Pre-treatment
Time frame: Pre-treatment (Baseline measurement)
FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose
Time frame: 1 week after last dose
FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose
Time frame: 4 weeks after last dose
PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge
Time frame: Pre-treatment, pre allergen challenge
PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge
Time frame: Pre-treatment, post allergen challenge
PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 1 week after last dose, pre allergen challenge
PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 1 week after last dose, post allergen challenge
PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 4 weeks after last dose, pre allergen challenge
PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge
Time frame: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge
Time frame: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge
Time frame: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge
Time frame: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge
Time frame: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge
Time frame: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge
Time frame: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge
Time frame: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge
Time frame: Pre-treatment, pre allergen challenge
Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge
Time frame: Pre-treatment, post allergen challenge
Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 1 week after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 1 week after last dose, post allergen challenge
Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 4 weeks after last dose, pre allergen challenge
Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 4 weeks after last dose, post allergen challenge
Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge
Time frame: Pre-treatment, pre allergen challenge

Results and safety

Results posted to the registry on 26 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD8848, 30 μg	6	6
AZD8848, 60 μg	0	0
Placebo	3	3

Primary outcome: FEV1, Late Asthmatic Response (LAR) - Pre-treatment

Time frame: Pre-treatment (Baseline measurement). Mean (Standard Deviation). Unit: ratio

Measure	AZD8848, 30 μg n = 0	AZD8848, 60 μg n = 22	Placebo n = 23
Value	–	0.814 (0.450)	1.01 (0.784)

Population analysed: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.

Primary outcome: FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose

Time frame: 1 week after last dose. Mean (Standard Deviation). Unit: ratio

Measure	AZD8848, 30 μg n = 0	AZD8848, 60 μg n = 22	Placebo n = 23
Value	–	0.616 (0.296)	0.970 (0.641)

Primary outcome: FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose

Time frame: 4 weeks after last dose. Mean (Standard Deviation). Unit: ratio

Measure	AZD8848, 30 μg n = 0	AZD8848, 60 μg n = 22	Placebo n = 21
Value	–	0.759 (0.397)	0.722 (0.584)

87 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD8848, 30 μg	0 of ?	6 of ?	Not reported
AZD8848, 60 μg	0 of ?	22 of ?	Not reported
Placebo	1 of ?	24 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31856838Leaker 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.
CSR SynopsisLink provided by the sponsor.

Related trials for Allergic Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leif Eriksson, MD study director

AstraZeneca R&D Lund

Brian Leaker, MD principal investigator

Respiratory Clinical Trials

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD8848 in people with Allergic Asthma, run by AstraZeneca at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1, Late Asthmatic Response (LAR) - Pre-treatment (time frame: Pre-treatment (Baseline measurement)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00999466, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.