Allergic RhinitisPhase 1NCT01537692
Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol
A Phase 1 study testing BDP HFA Nasal Aerosol and BDP HFA Inhalation Aerosol (QVAR) in people with Allergic Rhinitis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- BDP HFA Nasal Aerosol and BDP HFA Inhalation Aerosol (QVAR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed Consent
- Male or female subjects 18-45 years of age
- General good health
Who cannot join
- 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
About this study
Official title: A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers
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.
- Conditions
- Allergic Rhinitis
- Being tested
- BDP HFA Nasal Aerosol, BDP HFA Inhalation Aerosol (QVAR)
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDP HFA Nasal AerosolDrug
BDP HFA Nasal 80mcg
BDP HFA Nasal AerosolDrug
BDP HFA Nasal 320mcg
BDP HFA Inhalation Aerosol (QVAR)Drug
BDP HFA Oral 320mcg
| Study group | Role | What they receive |
|---|---|---|
| BDP HFA Nasal Aerosol 80 mcg/d | Experimental | single dose, intranasal aerosol Receives: Drug: BDP HFA Nasal Aerosol |
| BDP HFA Nasal Aerosol 320 mcg/d | Experimental | single dose, intranasal aerosol Receives: Drug: BDP HFA Nasal Aerosol |
| BDP HFA Inhalation Aerosol 320 mcg/d | Active comparator | single dose, orally inhaled aerosol Receives: Drug: BDP HFA Inhalation Aerosol (QVAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
- Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP
- Maximum plasma concentration (Cmax) for 17-BMP
Measured: 24 hours post dose
Secondary outcomes (2)
Pharmacokinetics
- 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
Measured: 24 hours post dose
Safety and tolerability of BDP HFA nasal aerosol
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)
Measured: 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMar 2009
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudeesh Tantry, PhD, Study director, Teva Global Respiratory Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537692
- Sponsor's protocol ID
- BDP-AR-101
- Status last verified
- Feb 2012
- First submitted
- 15 Feb 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ratner PH, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Pharmacokinetic profile of beclomethasone dipropionate hydrofluoroalkane after intranasal administration versus oral inhalation in healthy subjects: results of a single-dose, randomized, open-label, 3-period crossover study. Clin Ther. 2012 Jun;34(6):1422-31. doi: 10.1016/j.clinthera.2012.04.023. Epub 2012 May 22.
PubMed 22621776
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01537692
- Acronym / sponsor ID
- BDP-AR-101
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BDP HFA Nasal Aerosol 80 mcg/d | Experimental | Drug: BDP HFA Nasal Aerosolsingle dose, intranasal aerosol |
| BDP HFA Nasal Aerosol 320 mcg/d | Experimental | Drug: BDP HFA Nasal Aerosolsingle dose, intranasal aerosol |
| BDP HFA Inhalation Aerosol 320 mcg/d | Active comparator | Drug: BDP HFA Inhalation Aerosol (QVAR)single dose, orally inhaled aerosol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Informed Consent
- Male or female subjects 18-45 years of age
- General good health
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDP HFA Nasal AerosolBDP HFA Nasal 80mcg | Drug | BDP HFA Nasal Aerosol 80 mcg/d |
| BDP HFA Nasal AerosolBDP HFA Nasal 320mcg | Drug | BDP HFA Nasal Aerosol 320 mcg/d |
| BDP HFA Inhalation Aerosol (QVAR)BDP HFA Oral 320mcg | Drug | BDP HFA Inhalation Aerosol 320 mcg/d |
Primary outcome
Pharmacokinetics
Time frame: 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
2 secondary outcomes
Pharmacokinetics
Time frame: 24 hours post dose
Safety and tolerability of BDP HFA nasal aerosol
Time frame: 24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
- Derived from this study: PubMed 22621776Ratner PH, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Pharmacokinetic profile of beclomethasone dipropionate hydrofluoroalkane after intranasal administration versus oral inhalation in healthy subjects: results of a single-dose, randomized, open-label, 3-period crossover study. Clin Ther. 2012 Jun;34(6):1422-31. doi: 10.1016/j.clinthera.2012.04.023. Epub 2012 May 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudeesh Tantry, PhD study director
Teva Global Respiratory Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BDP HFA Nasal Aerosol and BDP HFA Inhalation Aerosol (QVAR) in people with Allergic Rhinitis, run by Teva Branded Pharmaceutical Products R&D, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 24 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01537692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.