Perennial Allergic RhinitisPhase 3NCT01133626
Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)
A Phase 3 study testing Prednisone capsules and Beclomethasone dipropionate in people with Perennial Allergic Rhinitis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in United States.
Trial summary
The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Prednisone capsules and Beclomethasone dipropionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2010to Sep 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed Consent
- Male or female subjects 12-45 years of age
- Documented history of perennial allergic rhinitis
- General good health
- Other criteria apply
Who cannot join
- History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1)
- Participation in any investigational drug study 30 days preceding Screening Visit 1
- History of respiratory infection/disorder with 14 days preceding Screening Visit 1
- Use of any prohibited concomitant medications
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Teva Clinical Study Site
New Braunfels, Texas, 78130
Teva Clinical Study Site
North Dartmouth, Massachusetts, 02747
Teva Clinical Study Site
San Antonio, Texas, 78229
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 to 45 Years of Age) With Perennial Allergic Rhinitis (PAR)
The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Placebo Nasal Aerosol, Prednisone capsules, Placebo Prednisone Capsules, Beclomethasone dipropionate
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Nasal AerosolDrug
Placebo nasal aerosol administered daily for 42 days of treatment
Prednisone capsulesDrug
Prednisone 10 mg capsule taken each day on the last 7 days of treatment
Placebo Prednisone CapsulesDrug
Placebo prednisone capsule taken each day on the last 7 days of treatment
Beclomethasone dipropionateDrug
Also called QNASL(TM)
Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. Receives: Drug: Placebo Nasal Aerosol; Drug: Placebo Prednisone Capsules |
| BDP HFA 320 µg/day | Experimental | Participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. Receives: Drug: Placebo Prednisone Capsules; Drug: Beclomethasone dipropionate |
| Prednisone | Active comparator | Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule. Receives: Drug: Placebo Nasal Aerosol; Drug: Prednisone capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment
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.
Measured: Day 0 (Baseline), Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perennial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 107 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 K. Tantry, Ph.D., Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133626
- Sponsor's protocol ID
- BDP-AR-304
- Status last verified
- May 2012
- First submitted
- 27 May 2010
- Last updated
- 4 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hampel FC, Ratner PH, Miller SD, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol (320 mcg/d) is not associated with hypothalamic-pituitary-adrenal axis suppression in adolescent subjects with perennial allergic rhinitis. J Allergy Clin Immunol 2012; 129:AB188
Ratner PH, Miller SD, Hampel FC, A, Dunbar SA, Tantry SK, Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily g Once Daily Is Not Associated with HPA-Axis Suppression in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
Ratner PH, Miller SD, Hampel FC Jr, Melchior A, Dunbar SA, Tantry SK. Once-daily treatment with beclomethasone dipropionate nasal aerosol does not affect hypothalamic-pituitary-adrenal axis function. Ann Allergy Asthma Immunol. 2012 Nov;109(5):336-41. doi: 10.1016/j.anai.2012.08.005.
PubMed 23062389
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 to 45 Years of Age) With Perennial Allergic Rhinitis (PAR)
- ClinicalTrials.gov ID
- NCT01133626
- Acronym / sponsor ID
- BDP-AR-304
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Posted 4 Jul 2012
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 the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Nasal Aerosol, Drug: Placebo Prednisone CapsulesParticipants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. |
| BDP HFA 320 µg/day | Experimental | Drug: Placebo Prednisone Capsules, Drug: Beclomethasone dipropionateParticipants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. |
| Prednisone | Active comparator | Drug: Placebo Nasal Aerosol, Drug: Prednisone capsulesParticipants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Informed Consent
- Male or female subjects 12-45 years of age
- Documented history of perennial allergic rhinitis
- General good health
- Other criteria apply
Key exclusion criteria (4 listed)
- History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1)
- Participation in any investigational drug study 30 days preceding Screening Visit 1
- History of respiratory infection/disorder with 14 days preceding Screening Visit 1
- Use of any prohibited concomitant medications
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 |
|---|---|---|
| Placebo Nasal AerosolPlacebo nasal aerosol administered daily for 42 days of treatment | Drug | Placebo, Prednisone |
| Prednisone capsulesPrednisone 10 mg capsule taken each day on the last 7 days of treatment | Drug | Prednisone |
| Placebo Prednisone CapsulesPlacebo prednisone capsule taken each day on the last 7 days of treatment | Drug | BDP HFA 320 µg/day, Placebo |
| Beclomethasone dipropionateAlso: QNASL(TM)Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days. | Drug | BDP HFA 320 µg/day |
Primary outcome
The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment
Time frame: Day 0 (Baseline), Day 42
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationHampel FC, Ratner PH, Miller SD, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol (320 mcg/d) is not associated with hypothalamic-pituitary-adrenal axis suppression in adolescent subjects with perennial allergic rhinitis. J Allergy Clin Immunol 2012; 129:AB188
- Results publicationRatner PH, Miller SD, Hampel FC, A, Dunbar SA, Tantry SK, Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily g Once Daily Is Not Associated with HPA-Axis Suppression in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
- Derived from this study: PubMed 23062389Ratner PH, Miller SD, Hampel FC Jr, Melchior A, Dunbar SA, Tantry SK. Once-daily treatment with beclomethasone dipropionate nasal aerosol does not affect hypothalamic-pituitary-adrenal axis function. Ann Allergy Asthma Immunol. 2012 Nov;109(5):336-41. doi: 10.1016/j.anai.2012.08.005.
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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 K. Tantry, Ph.D. study director
Teva Branded Pharmaceutical Products R&D, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisone capsules and Beclomethasone dipropionate in people with Perennial Allergic Rhinitis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in United States.
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 5 inclusion and 4 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 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment (time frame: Day 0 (Baseline), Day 42). 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 NCT01133626, which also lists 3 linked publications.
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 4 Jul 2012.