Trial · NCT01024608
Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
NCT01024608, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2012-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR). Trials, record NCT01024608. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01024608
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
- NCT number
- NCT01024608
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 340 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Seasonal Allergic Rhinitis, Hay Fever
- Interventions
- Beclomethasone dipropionate, Placebo Nasal Aerosol
- First posted
- 2009-12-03
- Last updated
- 2021-12-03
- Results first posted
- 2012-05-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period | Baseline (Days -3 to 0), and Days 1-15 | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping). The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement. |
| Secondary | Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period | Baseline (Days -3 to 0), and Days 1-15 | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The iTNSS (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement. |
| Secondary | Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | Day 0 (Baseline), Day 15 | The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement. |
| Secondary | Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period | Baseline (Days -3 to 0), and Days 1-15 | Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities). The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period | Baseline (Days -3 to 0), and Days 1-15 | Intent to treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period | Baseline (Days -3 to 0), and Days 1-15 | Intent to treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | Day 0 (Baseline), Day 15 | The RQLQ population, subset of ITT population, included only those participants over the age of 18 years (fluent in English) with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period | Baseline (Days -3 to 0), and Days 1-15 | Intent to treat population | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period | BDP HFA 320 µg/Day | -2.0 | Standard Error 0.16 | units on a scale | |
| Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period | Placebo | -1.0 | Standard Error 0.15 | units on a scale | |
| Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period | BDP HFA 320 µg/Day | -1.7 | Standard Error 0.15 | units on a scale | |
| Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period | Placebo | -0.8 | Standard Error 0.15 | units on a scale | |
| Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | BDP HFA 320 µg/Day | -1.2 | Standard Error 0.12 | units on a scale | |
| Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | Placebo | -0.8 | Standard Error 0.12 | units on a scale | |
| Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period | BDP HFA 320 µg/Day | -1.3 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period | Placebo | -0.7 | Standard Error 0.12 | units on a scale |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BDP HFA 320 µg/Day | 169 | |
| Overall Study | STARTED | Placebo | 171 | |
| Overall Study | Intent to Treat Population | BDP HFA 320 µg/Day | 167 | |
| Overall Study | Intent to Treat Population | Placebo | 171 | |
| Overall Study | Safety Population | BDP HFA 320 µg/Day | 167 | |
| Overall Study | Safety Population | Placebo | 171 | |
| Overall Study | COMPLETED | BDP HFA 320 µg/Day | 165 | |
| Overall Study | COMPLETED | Placebo | 167 | |
| Overall Study | NOT COMPLETED | BDP HFA 320 µg/Day | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | BDP HFA 320 µg/Day | 11 | 167 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Placebo | 10 | 171 | |
| serious | Hypertensive crisis | Vascular disorders | BDP HFA 320 µg/Day | 1 | 167 | |
| serious | Hypertensive crisis | Vascular disorders | Placebo | 0 | 171 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BDP HFA 320 µg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | BDP HFA 320 µg/Day | 11 | 167 |
| Total, other adverse events | Placebo | 10 | 171 |
| Total, serious adverse events | BDP HFA 320 µg/Day | 1 | 167 |
| Total, serious adverse events | Placebo | 0 | 171 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23026180 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BDP HFA 320 µg/Day vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01024608
GET https://conductscience.org/api/trials/v1/NCT01024608/registered