Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848

A Phase 2 study testing AZD8848 in people with Allergic Rhinitis, run by AstraZeneca at 2 sites in Sweden.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Allergic Rhinitis
What is being tested?: AZD8848
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 93 participants
Where: 2 sitesSweden
Study dates: Sep 2010to Jan 2012
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

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

Research Site
Helsingborg
Research Site
Lund, Malmohus Lan

Other trials in Sweden

About this study

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

Read the 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

Conditions: Allergic Rhinitis
Being tested: AZD8848, Placebo, AZD8848 and placebo
Keywords: AZD8848, allergic rhinitis, efficacy, tolerability, safety, nasal symptoms
Medical subject headings: Rhinitis, Allergic

What participants receive

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

AZD8848Drug
Nasal spray solution, intranasal, three times weekly for one month
PlaceboDrug
Nasal spray solution, intranasal, three times weekly for one month
AZD8848 and placeboDrug
Nasal spray solution, intranasal, three times weekly for one month

Study groups in NCT01185080
Study group	Role	What they receive
1. AZD8848	Experimental	20 μg AZD8848 three times weekly Receives: Drug: AZD8848
2. Placebo	Placebo comparator	Placebo three times weekly Receives: Drug: Placebo
3. AZD8848 and placebo	Experimental	60 μg AZD8848 once weekly and placebo twice weekly Receives: Drug: AZD8848 and placebo

What is being measured

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

Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.
Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Measured: During 1st day to 7th day of Allergen challenge period.
Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Measured: During 4th day to 7th day of Allergen challenge period.
Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Measured: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Measured: During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.
Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. 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.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Measured: During 1st day to 7th day of Allergen challenge period.
Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. 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.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Measured: During 4th day to 7th day of Allergen challenge period.
Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. 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.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Measured: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. 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.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Measured: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.

Secondary outcomes (6)

Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicate worse outcome.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2.
Measured: Pre-dose on visit 2 (baseline)
Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11.
Measured: Pre-dose on visit 11 (end of 3rd week of treatment)
Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. 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.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2.
Measured: Pre-dose on visit 2 (baseline)
Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. 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.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11.
Measured: Pre-dose on visit 11 (end of 3rd week of treatment)
Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma
Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in plasma, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.
Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit15.
Measured: Baseline to 1st day of visit 15
Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage
Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in nasal lavage, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.
Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit 15.
Measured: Baseline to 1st day of visit 15

Timeline

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

Sep 2010Jan 2012

First posted19 Aug 2010 (estimated)
Study startSep 2010
Primary completionDec 2010
Study completionJan 2012

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 RhinitisStudies 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: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01185080
Sponsor's protocol ID: D0540C00014
Other IDs: 2010-020747-13
Status last verified: Dec 2015
First submitted: 11 Aug 2010
Last updated: 7 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26342289

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

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
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
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)

All Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 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 Different Dosing Regimens of AZD8848 Administered Intranasally to Seasonal Allergic Rhinitis Patients Out of Pollen Season in a Nasal Allergen Challenge Model
ClinicalTrials.gov ID: NCT01185080
Acronym / sponsor ID: D0540C00014
Conditions: Allergic Rhinitis
Keywords: AZD8848, allergic rhinitis, efficacy, tolerability, safety, nasal symptoms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Dec 2010 (actual)
Study completion: Jan 2012 (actual)
First posted: 19 Aug 2010 (estimated)
Results: Posted 7 Jan 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1. AZD8848	Experimental	Drug: AZD884820 μg AZD8848 three times weekly
2. Placebo	Placebo comparator	Drug: PlaceboPlacebo three times weekly
3. AZD8848 and placebo	Experimental	Drug: AZD8848 and placebo60 μg AZD8848 once weekly and placebo twice weekly

Who may qualify

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

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

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, intranasal, three times weekly for one month	Drug	1. AZD8848
PlaceboNasal spray solution, intranasal, three times weekly for one month	Drug	2. Placebo
AZD8848 and placeboNasal spray solution, intranasal, three times weekly for one month	Drug	3. AZD8848 and placebo

Primary outcome

Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
Time frame: During 1st day to 7th day of Allergen challenge period.
Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
Time frame: During 4th day to 7th day of Allergen challenge period.
Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
Time frame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
Time frame: During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.
Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
Time frame: During 1st day to 7th day of Allergen challenge period.
Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. 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. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
Time frame: During 4th day to 7th day of Allergen challenge period.
Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. 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. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
Time frame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. 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. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
Time frame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. 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. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).

6 secondary outcomes

Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
Time frame: Pre-dose on visit 2 (baseline)
Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
Time frame: Pre-dose on visit 11 (end of 3rd week of treatment)
Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
Time frame: Pre-dose on visit 2 (baseline)
Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
Time frame: Pre-dose on visit 11 (end of 3rd week of treatment)
Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma
Time frame: Baseline to 1st day of visit 15
Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage
Time frame: Baseline to 1st day of visit 15

Results and safety

Results posted to the registry on 7 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 20 μg x3	50	49
Placebo	16	15
AZD8848 60 μg	17	16

Primary outcome: Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)

Time frame: During 1st day to 7th day of Allergen challenge period.. Least squares mean (Full Range). Unit: Scores on a scale

Measure	AZD8848 20 μg x3 n = 50	Placebo n = 15	AZD8848 60 μg n = 16
Value	4.52 (1.43 to 7.71)	4.97 (2.86 to 6.43)	4.69 (3.14 to 7.00)

Primary outcome: Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)

Time frame: During 4th day to 7th day of Allergen challenge period.. Least squares mean (Full Range). Unit: Scores on a scale

Measure	AZD8848 20 μg x3 n = 49	Placebo n = 15	AZD8848 60 μg n = 16
Value	4.45 (1.25 to 8.25)	5.36 (3.25 to 8.00)	4.42 (2.75 to 7.50)

Primary outcome: Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)

Time frame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.. Least squares mean (Full Range). Unit: Scores on a scale

Measure	AZD8848 20 μg x3 n = 50	Placebo n = 14	AZD8848 60 μg n = 16
Value	1.81 (0.286 to 4.14)	2.14 (0.286 to 3.57)	1.48 (0.143 to 3.29)

Primary outcome: Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)

Time frame: During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.. Least squares mean (Full Range). Unit: Scores on a scale

Measure	AZD8848 20 μg x3 n = 50	Placebo n = 14	AZD8848 60 μg n = 16
Value	2.06 (0.143 to 4.71)	2.32 (0 to 4.57)	1.96 (0.143 to 4.43)

6 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 20 μg x3	0 of 50 (0%)	48 of 50 (96%)	Not reported
Placebo	0 of 16 (0%)	12 of 16 (75%)	Not reported
AZD8848 60 μg	0 of 17 (0%)	12 of 17 (70.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26342289Greiff 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.
CSR SynopsisLink provided by the sponsor.
ProtocolLink provided by the sponsor.

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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.

Lennart Greiff, MD, PhD principal investigator

Lund University Hospital, Sweden

Sam Lindgren, MD, PhD study director

AstraZeneca R&D Lund, Sweden

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 Rhinitis, run by AstraZeneca at 2 sites in Sweden.

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 2 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 7 Jan 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 Sweden. 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 7 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?

Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) (time frame: During 1st day to 7th day of Allergen challenge period.). The study lists 8 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 NCT01185080, 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 7 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.