Phase 2
N=83
Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848
Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01185080 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) — 4.52; 4.97; 4.69 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD8848 (Drug); Placebo (Drug); AZD8848 and placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) |
4.45; 5.36; 4.42 | — |
| PRIMARY Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) |
4.45; 5.36; 4.42 | — |
| PRIMARY Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) |
1.81; 2.14; 1.48 | — |
| PRIMARY Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) |
2.06; 2.32; 1.96 | — |
| PRIMARY Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) |
121; 128; 135 | — |
| PRIMARY Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) |
121; 128; 135 | — |
| PRIMARY Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) |
136; 148; 148 | — |
| PRIMARY of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) |
145; 149; 147 | — |
| SECONDARY Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) |
1.20; 0.67; 0.80 | — |
| SECONDARY Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) |
1.20; 0.67; 0.80 | — |
| SECONDARY Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) |
168.1; 191.3; 182.7 | — |
| SECONDARY Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) |
168.1; 191.3; 182.7 | — |
| SECONDARY Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma |
2.89; 0.803; 3.90 | — |
| SECONDARY Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage |
30.0; 1.66; 26.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01185080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.