At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
AZ compound +3 moredrug
Likely dose
AZ compound 40 mg orally three times daily for 12 weeksAI-extracted
Key inclusion· 1
- ✓Females must have negative urine pregnancy test at screening unless documented hysterectomy or postmenopausal.
Key exclusion· 2
- ✕Use of any investigational drugs within 30 days of screening.
- ✕Acute infection needing antibiotic treatment at screening.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2A, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of an Anti-Inflammatory Agent in Patients With Sinusitis
In Brief
A Phase 2 clinical trial evaluating AZ compound, Collection of Biological Specimens, and 2 other interventions for Nasal Polyps. Completed, enrolled 43 participants.
Detailed Summary
To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving signs and symptoms of disease in patients with sinusitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Polyps
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
First PostedAug 2016
Primary CompletionJan 2020
Study CompletionAug 2020
TodayJul 2026
First PostedAug 22, 2016
Enrollment StartJun 20, 2016
Primary CompletionJan 7, 2020
Study CompletionAug 10, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.9 years ago
Interventions
AZ compounddrug
40 mg three times daily po for 12 weeks
Collection of Biological Specimensother
collection of biomarkers for analysis of nasal disease
Intranasal corticosteroiddrug
QD Nasal Spray
Placebodrug
looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks