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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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BDP HFA Nasal Aerosol 80 mcg/d

single dose, intranasal aerosol

Group Type EXPERIMENTAL

BDP HFA Nasal Aerosol

Intervention Type DRUG

BDP HFA Nasal 80mcg

BDP HFA Nasal Aerosol 320 mcg/d

single dose, intranasal aerosol

Group Type EXPERIMENTAL

BDP HFA Nasal Aerosol

Intervention Type DRUG

BDP HFA Nasal 320mcg

BDP HFA Inhalation Aerosol 320 mcg/d

single dose, orally inhaled aerosol

Group Type ACTIVE_COMPARATOR

BDP HFA Inhalation Aerosol (QVAR)

Intervention Type DRUG

BDP HFA Oral 320mcg

Interventions

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BDP HFA Nasal Aerosol

BDP HFA Nasal 80mcg

Intervention Type DRUG

BDP HFA Nasal Aerosol

BDP HFA Nasal 320mcg

Intervention Type DRUG

BDP HFA Inhalation Aerosol (QVAR)

BDP HFA Oral 320mcg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes