Trial · NCT01134705
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
NCT01134705, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2012-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis). Trials, record NCT01134705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01134705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
- NCT number
- NCT01134705
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 474 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol, Placebo Nasal Aerosol
- First posted
- 2010-06-02
- Last updated
- 2012-05-23
- Results first posted
- 2012-05-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period | Baseline (Days -3 to 0) and Days 1-43 (6-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, awareness, 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 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 AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period | Baseline (Days -3 to 0) and Days 1-43 (6-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 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 symptoms, bothersome but tolerable); 3=severe (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. |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Baseline and Week 6 | 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 improvement. |
Source ClinicalTrials.gov
Outcomes3
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 AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period | Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) | Intent-to-Treat (ITT) Population: The ITT population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period | Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) | Intent to treat population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Baseline and Week 6 | The RQLQ population included adults (18 years and older) with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
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 AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period | BDP HFA 320 µg/Day | -2.5 | Standard Error 0.14 | units on a scale | |
| Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period | Placebo | -1.6 | Standard Error 0.14 | units on a scale | |
| Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period | BDP HFA 320 µg/Day | -2.1 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period | Placebo | -1.4 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | BDP HFA 320 µg/Day | -1.5 | Standard Error 0.14 | units on a scale | |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Placebo | -0.9 | Standard Error 0.14 | units on a scale |
Source ClinicalTrials.gov
Participant flow8
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 | 236 | |
| Overall Study | STARTED | Placebo | 238 | |
| Overall Study | Intent to Treat Population | BDP HFA 320 µg/Day | 232 | |
| Overall Study | Intent to Treat Population | Placebo | 234 | |
| Overall Study | COMPLETED | BDP HFA 320 µg/Day | 221 | |
| Overall Study | COMPLETED | Placebo | 216 | |
| Overall Study | NOT COMPLETED | BDP HFA 320 µg/Day | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 22 |
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 | 14 | 236 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Placebo | 12 | 238 | |
| serious | Arrhythmia | Cardiac disorders | BDP HFA 320 µg/Day | 1 | 236 | |
| serious | Arrhythmia | Cardiac disorders | Placebo | 0 | 238 |
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 | 14 | 236 |
| Total, other adverse events | Placebo | 12 | 238 |
| Total, serious adverse events | BDP HFA 320 µg/Day | 1 | 236 |
| Total, serious adverse events | Placebo | 0 | 238 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01134705
GET https://conductscience.org/api/trials/v1/NCT01134705/registered