Seasonal Allergic RhinitisPhase 3NCT01307319

Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

A Phase 3 study testing BDP HFA in people with Seasonal Allergic Rhinitis and SAR, run by Teva Branded Pharmaceutical Products R&D, Inc. at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age). Read more about this study

Who is it for?: Ages 6 to 11 years
Conditions the study is for: Seasonal Allergic Rhinitis, SAR
What is being tested?: BDP HFA
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 715 participants
Where: 45 sitesUnited States
Study dates: Mar 2011to Aug 2011
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 6 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV)
A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV).
A demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known to induce SAR through a standard skin prick test.
Other criteria apply

Who cannot join

History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit [SV])
History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza,) within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable
Have any conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial
Other criteria apply

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

United States45 sites

Teva Clinical Study Site
Austin, Texas, 78731
Teva Clinical Study Site
Bell, California, 90201
Teva Clinical Study Site
Bethesda, Maryland, 20814
Teva Clinical Study Site
Blue Bell, Pennsylvania, 19422
Teva Clinical Study Site
Bozeman, Montana, 597158
Teva Clinical Study Site
Brick, New Jersey, 08724
Teva Clinical Study Site
Burke, Virginia, 22015
Teva Clinical Study Site
Centennial, Colorado, 80112
Teva Clinical Study Site
Charleston, South Carolina, 20460
Teva Clinical Study Site
Collegeville, Pennsylvania, 19426
Teva Clinical Study Site
Colorado Springs, Colorado, 80907
Teva Clinical Study Site
Columbia, Missouri, 65203
Teva Clinical Study Site
Costa Mesa, California, 92626
Teva Clinical Study Site
Dallas, Texas, 75230
Teva Clinical Study Site
Dallas, Texas, 75246
Teva Clinical Study Site
El Paso, Texas, 79903
Teva Clinical Study Site
Fort Worth, Texas, 76132
Teva Clinical Study Site
Gainesville, Georgia, 30501
Teva Clinical Study Site
High Point, North Carolina, 27262
Teva Clinical Study Site
Houston, Texas, 77054
Teva Clinical Study Site
Indianapolis, Indiana, 43208
Teva Clinical Study Site
Kerrville, Texas, 78028
Teva Clinical Study Site
Lawrenceville, Georgia, 30046
Teva Clinical Study Site
Minneapolis, Minnesota, 55402
Teva Clinical Study Site
Mission Viejo, California, 92691
Teva Clinical Study Site
New Braunfels, Texas, 78130
Teva Clinical Study Site
Oklahoma City, Oklahoma, 73102
Teva Clinical Study Site
Orange, California, 92868
Teva Clinical Study Site
Orangeburg, South Carolina, 29119
Teva Clinical Study Site
Oxford, Alabama, 36203
Teva Clinical Study Site
Paramount, California, 90723
Teva Clinical Study Site
Philadelphia, Pennsylvania, 19115
Teva Clinical Study Site
Pittsburgh, Pennsylvania, 15241
Teva Clinical Study Site
Plymouth, Minnesota, 55441
Teva Clinical Study Site
Portland, Oregon, 97213
Teva Clinical Study Site
Richmond, Virginia, 23233
Teva Clinical Study Site
Rolla, Missouri, 65401
Teva Clinical Study Site
San Antonio, Texas, 78229
Teva Clinical Study Site
San Diego, California, 92120
Teva Clinical Study Site
San Diego, California, 92123
Teva Clinical Study Site
Savannah, Georgia, 31406
Teva Clinical Study Site
Stockbridge, Georgia, 30281
Teva Clinical Study Site
Stockton, California, 95207
Teva Clinical Study Site
Waco, Texas, 76712
Teva Clinical Study Site
Warrensburg, Missouri, 64093

Other trials in United States

About this study

Official title: Study of Two Doses of an Investigational Nasal Aerosol Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

Conditions: Seasonal Allergic Rhinitis, SAR
Being tested: BDP HFA, Placebo nasal aerosol
Keywords: Allergies, Hayfever
Medical subject headings: Rhinitis, Allergic, Seasonal, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BDP HFADrug
Also called BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) Nasal Aerosol, QNASL®
BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
Placebo nasal aerosolDrug
Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.

Study groups in NCT01307319
Study group	Role	What they receive
BDP HFA 80 mcg/day	Experimental	Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. Receives: Drug: BDP HFA
BDP HFA 160 mcg/day	Experimental	Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. Receives: Drug: BDP HFA
Placebo nasal aerosol once daily	Placebo comparator	Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days. Receives: Drug: Placebo nasal aerosol

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment
Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
- 0 = absent (no sign/symptom present)
- 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
- 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
- 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization.
Measured: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

Secondary outcomes (1)

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment
Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
- 0 = absent (no sign/symptom present)
- 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
- 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
- 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization.
Measured: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Aug 2011

First posted2 Mar 2011 (estimated)
Study startMar 2011
Primary completionJul 2011
Study completionAug 2011

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 (1)Papers the sponsor has linked to this study.
Other trials for Seasonal 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 715 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01307319
Sponsor's protocol ID: BDP-AR-305
Status last verified: Feb 2015
First submitted: 28 Feb 2011
Last updated: 20 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Storms WW, Segall N, Mansfield LE, Amar NJ, Kelley L, Ding Y, Tantry SK. Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2013 Nov;111(5):408-414.e1. doi: 10.1016/j.anai.2013.07.033. Epub 2013 Aug 28.
PubMed 24125150

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Seasonal Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Two Doses of an Investigational Nasal Aerosol Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
ClinicalTrials.gov ID: NCT01307319
Acronym / sponsor ID: BDP-AR-305
Conditions: Seasonal Allergic Rhinitis, SAR
Keywords: Allergies, Hayfever
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 715 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Jul 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 2 Mar 2011 (estimated)
Results: Posted 20 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BDP HFA 80 mcg/day	Experimental	Drug: BDP HFAParticipants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
BDP HFA 160 mcg/day	Experimental	Drug: BDP HFAParticipants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
Placebo nasal aerosol once daily	Placebo comparator	Drug: Placebo nasal aerosolParticipants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.

Who may qualify

Ages: 6 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV)
A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV).
A demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known to induce SAR through a standard skin prick test.
Other criteria apply

Key exclusion criteria (5 listed)

History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit [SV])
History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza,) within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable
Have any conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial
Other criteria apply

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 HFAAlso: BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) Nasal Aerosol, QNASL®BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.	Drug	BDP HFA 160 mcg/day, BDP HFA 80 mcg/day
Placebo nasal aerosolPlacebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.	Drug	Placebo nasal aerosol once daily

Primary outcome

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment
Time frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15
Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: * 0 = absent (no sign/symptom present) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization.

1 secondary outcome

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment
Time frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

Results and safety

Results posted to the registry on 20 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BDP HFA 80 mcg/Day	239	235
BDP HFA 160 mcg/Day	242	234
Placebo Nasal Aerosol Once Daily	234	227

Primary outcome: Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment

Time frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15. Least squares mean (Standard Error). Unit: units on a scale

Measure	BDP HFA 80 mcg/Day n = 238	BDP HFA 160 mcg/Day n = 241	Placebo Nasal Aerosol Once Daily n = 234
Value	-1.9 (0.14)	-2.0 (0.14)	-1.2 (0.14)

BDP HFA 80 mcg/Day vs Placebo Nasal Aerosol Once Daily: LSM treatment difference from placebo: -0.71 (95% CI -1.1 to -0.3), p <0.001, mixed-model for repeated measures (MMRM)
BDP HFA 160 mcg/Day vs Placebo Nasal Aerosol Once Daily: LSM treatment difference from placebo: -0.76 (95% CI -1.1 to -0.4), p <0.001, mixed-model for repeated measures (MMRM)

Population analysed: The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 1 to Week 6. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BDP HFA 80 mcg/Day	0 of 239 (0%)	0 of 239 (0%)	Not reported
BDP HFA 160 mcg/Day	0 of 241 (0%)	0 of 241 (0%)	Not reported
Placebo Nasal Aerosol Once Daily	0 of 234 (0%)	0 of 234 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24125150Storms WW, Segall N, Mansfield LE, Amar NJ, Kelley L, Ding Y, Tantry SK. Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2013 Nov;111(5):408-414.e1. doi: 10.1016/j.anai.2013.07.033. Epub 2013 Aug 28.

Related trials for Seasonal Allergic Rhinitis

RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
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Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
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Enrolling by invitationObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

45 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 BDP HFA in people with Seasonal Allergic Rhinitis and SAR, run by Teva Branded Pharmaceutical Products R&D, Inc. at 45 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 4 inclusion and 5 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 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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 20 Feb 2015). 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?

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment (time frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15). 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 NCT01307319, 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 20 Feb 2015.