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NCT01133626 · ClinicalTrials.gov registry record · Phase 3

Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)

A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 3
Development phase
107
Enrollment target

NCT01133626: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT01133626 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 107 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01133626, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 3
Development phase
107 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.

Primary Outcome

Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an "other pre-specified" outcome.

Interventions

  • DRUG Beclomethasone dipropionate
  • DRUG Placebo Nasal Aerosol
  • DRUG Prednisone capsules
  • DRUG Placebo Prednisone Capsules

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2010-06
Est. Completion 2010-09
Phase Phase 3

What the finished NCT01133626 record still lists

NCT01133626 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 4 interventions - of which Beclomethasone dipropionate is the first listed.

NCT01133626 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01133626 about?

NCT01133626 is a clinical study titled "Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)". The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.

What is the current status of trial NCT01133626?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2010-06. Estimated completion is 2010-09.

What interventions are being tested in trial NCT01133626?

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

Who is sponsoring clinical trial NCT01133626?

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 NCT01133626's enrollment target sits among peer trials

107 1666th of 2000 higher than 335 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01133626, the US trial registry maintained by the National Library of Medicine. NCT01133626 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.