Seasonal Allergic RhinitisPhase 2NCT00854360

Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR

A Phase 2 study testing Beclomethasone dipropionate HFA Nasal Aerosol in people with Seasonal Allergic Rhinitis and Hayfever, run by Teva Branded Pharmaceutical Products R&D, Inc. at 26 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Seasonal Allergic Rhinitis, Hayfever
What is being tested?: Beclomethasone dipropionate HFA Nasal Aerosol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 487 participants
Where: 26 sitesUnited States
Study dates: Mar 2009to May 2009
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female patients 12 years of age and older, as of the Screening Visit (SV).
General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
Other criteria apply

Who cannot join

Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study.
History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
Other criteria apply

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Teva Global Respiratory Research Study Site
Austin, Texas, 78713
Teva Global Respiratory Research Study Site
Bethesda, Maryland, 20814
Teva Global Respiratory Research Study Site
Blue Bell, Pennsylvania, 19422
Teva Global Respiratory Research Study Site
Brick, New Jersey, 08724
Teva Global Respiratory Research Study Site
Burke, Virginia, 22015
Teva Global Respiratory Research Study Site
Charleston, South Carolina, 29407
Teva Global Respiratory Research Study Site
Colorado Springs, Colorado, 08907
Teva Global Respiratory Research Study Site
Dallas, Texas, 75231
Teva Global Respiratory Research Study Site
Denver, Colorado, 08230
Teva Global Respiratory Research Study Site
Draper, Utah, 84020
Teva Global Respiratory Research Study Site
Gainesville, Georgia, 030501
Teva Global Respiratory Research Study Site
Indianapolis, Indiana, 46208
Teva Global Respiratory Research Study Site
Medford, Oregon, 97504
Teva Global Respiratory Research Study Site
Mission Viejo, California, 92691
Teva Global Respiratory Research Study Site
New Braunfels, Texas, 78130
Teva Global Respiratory Research Study Site
Overland Park, Kansas, 66210
Teva Global Respiratory Research Study Site
Pittsburgh, Pennsylvania, 15241
Teva Global Respiratory Research Study Site
Portland, Oregon, 97213
Teva Global Respiratory Research Study Site
Raleigh, North Carolina, 27607
Teva Global Respiratory Research Study Site
Richmond, Virginia, 23233
Teva Global Respiratory Research Study Site
San Antonio, Texas, 78229
Teva Global Respiratory Research Study Site
San Diego, California, 92120
Teva Global Respiratory Research Study Site
San Diego, California, 92123
Teva Global Respiratory Research Study Site
Savannah, Georgia, 31406
Teva Global Respiratory Research Study Site
St Louis, Missouri, 63141
Teva Global Respiratory Research Study Site
Upland, Pennsylvania, 19013

Other trials in United States

About this study

Official title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Range-Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Conditions: Seasonal Allergic Rhinitis, Hayfever
Being tested: Beclomethasone dipropionate HFA Nasal Aerosol, Placebo
Keywords: Seasonal Allergic Rhinitis, Hayfever
Medical subject headings: Rhinitis, Allergic, Seasonal

What participants receive

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

Beclomethasone dipropionate HFA Nasal AerosolDrug
Also called QNASL(TM)
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
PlaceboDrug
HFA Vehicle Aerosol

Study groups in NCT00854360
Study group	Role	What they receive
BDP HFA 80 µg/day	Experimental	During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily. Receives: Drug: Beclomethasone dipropionate HFA Nasal Aerosol; Drug: Placebo
BDP HFA 160 µg/day	Experimental	During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily. Receives: Drug: Beclomethasone dipropionate HFA Nasal Aerosol
BDP HFA 320 µg/day	Experimental	During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. Receives: Drug: Beclomethasone dipropionate HFA Nasal Aerosol
Placebo	Placebo comparator	During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).
The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Measured: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Secondary outcomes (5)

Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to the assessment, twice daily (AM \& PM) using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Measured: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
Change from Baseline in the morning patient-reported instantaneous TNSS. Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 10 minutes (prior to the assessment) in the morning on a scale from 0 (mild symptoms) to 3 (severe symptoms). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Measured: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates symptom improvement.
Measured: Baseline and Week 2
Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period
Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes and redness of eyes) for the past 24 hours each morning using the following scale:
0=absent (no sign/symptoms); 1=mild (sign/symptom present, minimal awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptom hard to tolerate, interfere with daily activities or sleeping).
The total ocular symptom score (sum of 3 symptom scores) ranges from 0 to 9 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Measured: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period
Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes and itching of ears or palate) for the past 24 hours each morning using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities or sleeping).
Total non-nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Measured: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Timeline

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

Mar 2009May 2009

First posted3 Mar 2009 (estimated)
Study startMar 2009
Primary completionMay 2009
Study completionMay 2009

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 487 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00854360
Sponsor's protocol ID: BDP-AR-201
Status last verified: Apr 2012
First submitted: 2 Mar 2009
Last updated: 22 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Raphael GD, Berger WE, Prenner BM, Finn AF Jr, Kelley L, Tantry SK. Efficacy, safety, and optimal dose selection of beclomethasone dipropionate nasal aerosol for seasonal allergic rhinitis in adolescents and adults. Curr Med Res Opin. 2013 Oct;29(10):1329-40. doi: 10.1185/03007995.2013.821055. Epub 2013 Aug 6.
PubMed 23815103

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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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Range-Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) With Seasonal Allergic Rhinitis (SAR)
ClinicalTrials.gov ID: NCT00854360
Acronym / sponsor ID: BDP-AR-201
Conditions: Seasonal Allergic Rhinitis, Hayfever
Keywords: Seasonal Allergic Rhinitis, Hayfever
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 487 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 3 Mar 2009 (estimated)
Results: Posted 22 May 2012

Clinical summary

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

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BDP HFA 80 µg/day	Experimental	Drug: Beclomethasone dipropionate HFA Nasal Aerosol, Drug: PlaceboDuring the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily.
BDP HFA 160 µg/day	Experimental	Drug: Beclomethasone dipropionate HFA Nasal AerosolDuring the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
BDP HFA 320 µg/day	Experimental	Drug: Beclomethasone dipropionate HFA Nasal AerosolDuring the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
Placebo	Placebo comparator	Drug: PlaceboDuring the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Male or female patients 12 years of age and older, as of the Screening Visit (SV).
General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
Other criteria apply

Key exclusion criteria (5 listed)

Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study.
History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
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
Beclomethasone dipropionate HFA Nasal AerosolAlso: QNASL(TM)Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol	Drug	BDP HFA 160 µg/day, BDP HFA 320 µg/day, BDP HFA 80 µg/day
PlaceboHFA Vehicle Aerosol	Drug	BDP HFA 80 µg/day, Placebo

Primary outcome

Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
Time frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.

5 secondary outcomes

Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period
Time frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
Time frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: Baseline and Week 2
Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period
Time frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period
Time frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Results and safety

Results posted to the registry on 22 May 2012, 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 µg/Day	118	116
BDP HFA 160 µg/Day	123	120
BDP HFA 320 µg/Day	122	120
Placebo	124	114

Primary outcome: Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period

Time frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period). Least squares mean (Standard Error). Unit: units on a scale

Measure	BDP HFA 80 µg/Day n = 118	BDP HFA 160 µg/Day n = 123	BDP HFA 320 µg/Day n = 122	Placebo n = 123
Value	-1.88 (0.18)	-1.87 (0.18)	-2.22 (0.18)	-1.59 (0.18)

BDP HFA 80 µg/Day vs Placebo: LS Mean Difference: -0.29 (95% CI -0.80 to 0.21), p = 0.255, Repeated measures ANCOVA
BDP HFA 160 µg/Day vs Placebo: LS Mean Difference: -0.29 (95% CI -0.78 to 0.21), p = 0.257, Repeated measures ANCOVA
BDP HFA 320 µg/Day vs Placebo: LS Mean Difference: -0.63 (95% CI -1.13 to -0.13), p = 0.013, Repeated measures ANCOVA

Population analysed: The Intent-to-treat population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BDP HFA 80 µg/Day	0 of 118 (0%)	6 of 118 (5.1%)	Not reported
BDP HFA 160 µg/Day	2 of 123 (1.6%)	3 of 123 (2.4%)	Not reported
BDP HFA 320 µg/Day	0 of 122 (0%)	3 of 122 (2.5%)	Not reported
Placebo	0 of 123 (0%)	1 of 123 (0.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23815103Raphael GD, Berger WE, Prenner BM, Finn AF Jr, Kelley L, Tantry SK. Efficacy, safety, and optimal dose selection of beclomethasone dipropionate nasal aerosol for seasonal allergic rhinitis in adolescents and adults. Curr Med Res Opin. 2013 Oct;29(10):1329-40. doi: 10.1185/03007995.2013.821055. Epub 2013 Aug 6.

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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, Ph.D. study chair

Teva Branded Pharmaceutical Products R&D, Inc.

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 May 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?

Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period (time frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)). 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 NCT00854360, 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 22 May 2012.