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

Phase 1

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: BDP HFA Nasal Aerosol; Drug: BDP HFA Inhalation Aerosol (QVAR)

• Registration Number: NCT01537692
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-04
• Study Completion: 2009-06
• Status Verified: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-22
• Last Update Submitted: 2012-02-22
• Study First Posted: 2012-02-23
• Last Update Posted: 2012-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BDP HFA Nasal Aerosol 80 mcg/d	BDP HFA Nasal Aerosol	single dose, intranasal aerosol
BDP HFA Nasal Aerosol 320 mcg/d	BDP HFA Nasal Aerosol	single dose, intranasal aerosol
BDP HFA Inhalation Aerosol 320 mcg/d	BDP HFA Inhalation Aerosol (QVAR)	single dose, orally inhaled aerosol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)