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Completed

NCT Number: NCT01185080

Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Lund, Malmohus Lan, Sweden

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

AZD8848

Drug

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

Placebo

Drug

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

AZD8848 and placebo

Drug

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

Secondary outcomes

  1. 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) 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.

  2. 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 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.

  3. 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) 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.

  4. Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)

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

    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.

  5. 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 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.

  6. Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage

    Time frame: Baseline to 1st day of visit 15

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Aug 19, 2010
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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