CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 487 enrolled
Drug / intervention
Beclomethasone dipropionate HFA Nasal Aerosol +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age ≥12 years at screening
  • ✓General good health without concomitant conditions or treatments that could interfere with study conduct or put patient at increased risk
  • ✓History of SAR to tree/grass pollen for minimum 2 years prior to screening, with past treatment requirement and expected allergen exposure during study
  • ✓Demonstrated sensitivity to tree/grass pollen by skin prick test with wheal ≥3 mm larger than control, within 12 months of screening
Key exclusion· 4
  • ✕Participation in any investigational drug study within 30 days before screening or planned participation during this study
  • ✕History of nasal pathology including nasal polyps, malformations, recent biopsy, trauma, surgery, atrophic rhinitis, or rhinitis medicamentosa within 60 days prior to screening
  • ✕Respiratory infection or disorder (bronchitis, pneumonia, chronic sinusitis, influenza, SARS) within 14 days before screening or during run-in period
  • ✕Use of prohibited concomitant medications within prescribed timeframe prior to screening and/or during treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00854360
NCT00854360Phase 2Completed
CompareCT.gov

Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Range-Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Mar 3, 2009·Updated May 22, 2012

In Brief

A Phase 2 clinical trial evaluating Beclomethasone dipropionate HFA Nasal Aerosol and Placebo for Seasonal Allergic Rhinitis and Hayfever. Completed, enrolled 487 participants across 26 sites.

Detailed Summary

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis, Hayfever
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 3, 2009
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.3 years ago

Interventions

Beclomethasone dipropionate HFA Nasal Aerosoldrug

Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol

Placebodrug

HFA Vehicle Aerosol