Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol

A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01537692

Enrollment

Registered

2012-02-23

Start date

2009-03-31

Completion date

2009-06-30

Last updated

2012-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Brief summary

The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.

Interventions

DRUGBDP HFA Nasal Aerosol

BDP HFA Nasal 80mcg

DRUGBDP HFA Inhalation Aerosol (QVAR)

BDP HFA Oral 320mcg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Informed Consent * Male or female subjects 18-45 years of age * General good health

Exclusion criteria

* History of physical findings of nasal pathology (within 60 days prior to Screening Visit) * Participation in any investigational drug study 30 days preceding Screening Visit * History of respiratory infection/disorder with 28 days preceding Screening Visit

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics	24 hours post dose	* Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP * Maximum plasma concentration (Cmax) for 17-BMP

Secondary

Measure	Time frame	Description
Pharmacokinetics	24 hours post dose	* Area under the plasma concentration time curve extrapolated to infinity (AUC0-inf), time to mean peak plasma concentration (Tmax), and the terminal elimination half-life (t1/2) for 17-BMP * AUClast, AUC0-inf, Cmax, Tmax, t1/2 for BDP
Safety and tolerability of BDP HFA nasal aerosol	24 hours post dose	Change from baseline in safety and tolerability endpoints - including Adverse events, changes in vital signs (blood pressure and pulse rate) and ENT exams (every visit) and safety laboratory assessments and physical exams (end of study)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026