Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848

NCT01185080 | Completed Phase 2 Results

• 2 other identifiers: D0540C000142010-020747-13
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Allergic Rhinitis

Keywords

AZD8848; allergic rhinitis; efficacy; tolerability; safety; nasal symptoms

Outcome Measures

Primary Outcomes (8)

• 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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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)

  Pre-dose on visit 2 (baseline)

• Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)

  Pre-dose on visit 11 (end of 3rd week of treatment)

• Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)

  Pre-dose on visit 2 (baseline)

• Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)

  Pre-dose on visit 11 (end of 3rd week of treatment)

• Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma

  Baseline to 1st day of visit 15

Study Arms (3)

1. AZD8848

EXPERIMENTAL

20 μg AZD8848 three times weekly

Drug: AZD8848

2. Placebo

PLACEBO COMPARATOR

Placebo three times weekly

Drug: Placebo

3. AZD8848 and placebo

EXPERIMENTAL

60 μg AZD8848 once weekly and placebo twice weekly

Drug: AZD8848 and placebo

Interventions

AZD8848 DRUG

Nasal spray solution, intranasal, three times weekly for one month

1. AZD8848

Placebo DRUG

Nasal spray solution, intranasal, three times weekly for one month

2. Placebo

AZD8848 and placebo DRUG

Nasal spray solution, intranasal, three times weekly for one month

3. AZD8848 and placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Lund, Malmohus Lan, Sweden

Location

Research Site

Helsingborg, Sweden

Location

Related Publications (1)

• 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: 26342289 DERIVED

Related Links

• CSR Synopsis
• Protocol

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

AZD8848

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Lennart Greiff, MD, PhD

  Lund University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

• Sam Lindgren, MD, PhD

  AstraZeneca R&D Lund, Sweden

  STUDY DIRECTOR

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: August 11, 2010
• First Posted: August 19, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2012
• Last Updated: January 7, 2016
• Results First Posted: January 7, 2016

Record last verified: 2015-12

Locations

SE (2)