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NCT00854360 · ClinicalTrials.gov registry record · Phase 2

Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR

A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 2
Development phase
487
Enrollment target

NCT00854360: Completed Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT00854360 is a Phase 2 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 487 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (266% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00854360, a Phase 2 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 2
Development phase
487 participants
Enrollment target

Study 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.

Primary Outcome

Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 t

Interventions

  • DRUG Placebo
  • DRUG Beclomethasone dipropionate HFA Nasal Aerosol

Trial Details

FieldValue
Enrollment Target 487 participants
Start Date 2009-03
Est. Completion 2009-05
Phase Phase 2

What the finished NCT00854360 record still lists

NCT00854360 is an interventional study that assigns participants to a tested intervention. The registered 487 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (266% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00854360 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00854360 about?

NCT00854360 is a clinical study titled "Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR". 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.

What is the current status of trial NCT00854360?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 487 participants. The study started on 2009-03. Estimated completion is 2009-05.

What interventions are being tested in trial NCT00854360?

The interventions under investigation include: Placebo (DRUG), Beclomethasone dipropionate HFA Nasal Aerosol (DRUG).

Who is sponsoring clinical trial NCT00854360?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00854360's enrollment target sits among peer trials

487 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00854360, the US trial registry maintained by the National Library of Medicine. NCT00854360 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.