Phase 2
N=20
The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01225549 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1 — 90.97; 91.32; 87.28; 85.83 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD5423 (Drug); Budesonide 200 microgram (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1 |
90.97; 91.32; 87.28; 85.83 | — |
| SECONDARY Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge |
69.75; 69.57; 67.98; 69.30 | — |
| SECONDARY Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge |
83.82; 83.71; 81.90; 82.26; 96.30; 96.53 | — |
| SECONDARY Airway Hyperresponsiveness by Assessment of Methacholine PC20 |
2.017; 2.007; 1.666; 1.214 | — |
| SECONDARY Airway Hyperresponsiveness by Assessment of Methacholine PC20 |
2.017; 2.007; 1.666; 1.214 | — |
| SECONDARY Airway Hyperresponsiveness by Assessment of Methacholine PC20 |
2.017; 2.007; 1.666; 1.214 | — |
| SECONDARY Changes in Sputum Eosinophils Differentials (Percentage) |
0.688; 2.286; 6.967; 5.634 | — |
| SECONDARY Changes in Sputum Eosinophils Differentials (Percentage) |
0.688; 2.286; 6.967; 5.634 | — |
| SECONDARY Changes in Sputum Eosinophils Differentials (Percentage) |
0.688; 2.286; 6.967; 5.634 | — |
Summary
The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.
Eligibility Criteria
Inclusion Criteria
- 18-60 years of age
- Pre-bronchodilatory FEV1 ≥70% of predicted normal allergic asthmatic with a history of episodic wheeze
- Positive allergen induced early and late airway bronchoconstriction showing ≥ 20% fall in FEV1 for the early and ≥ 15% for the late response
- Positive skin prick test to common aeroallergens
Exclusion Criteria
- Any clinically significant disease or disorder
- Any clinically relevant abnormal finding at screening examinations
- Smoker or ex-smoker who has stopped smoking < 12 months prior to study start
- Worsening of asthma or respiratory infection within 6 weeks from visit 1
- Allergen-specific immunotherapy within 6 months prior to visit 1
Data sourced from ClinicalTrials.gov (NCT01225549). 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.