Trial · NCT00988247
Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
NCT00988247, 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. Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis. Trials, record NCT00988247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00988247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
- NCT number
- NCT00988247
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 529 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Beclomethasone dipropionate, Placebo Nasal Aerosol
- First posted
- 2009-10-02
- Last updated
- 2021-12-03
- Results first posted
- 2012-05-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks | Baseline (Days -6 to 0), Day 1 to Week 30 | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement. |
| Secondary | Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks | Baseline (Days -6 to 0), Day 1 to Week 30 | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement. |
| Secondary | Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks | Baseline (Days -6 to 0), Day 1 to Week 52 | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement. |
| Secondary | Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks | Baseline (Days -6 to 0), Day 1 to Week 52 | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement. |
| Secondary | Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | Day 0 (Baseline) and Week 30 | 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. Week 30 scores were compared to baseline scores. A negative change score indicates improvement. |
| Secondary | Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | Day 0 (Baseline) and Week 52 | 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. Week 52 scores were compared to baseline scores. A negative change score indicates improvement. |
Source ClinicalTrials.gov
Outcomes6
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-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks | Baseline (Days -6 to 0), Day 1 to Week 30 | Intent to treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks | Baseline (Days -6 to 0), Day 1 to Week 30 | Intent to treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks | Baseline (Days -6 to 0), Day 1 to Week 52 | Intent to treat population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks | Baseline (Days -6 to 0), Day 1 to Week 52 | Intent to treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | Day 0 (Baseline) and Week 30 | The RQLQ population included only those participants over the age of 18 years 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 to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | Day 0 (Baseline) and Week 52 | The RQLQ population included only those participants over the age of 18 years 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 |
Source ClinicalTrials.gov
Results by group12
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-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks | BDP HFA 320 µg/Day | -3.4 | Standard Error 0.11 | units on a scale | |
| Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks | Placebo | -2.4 | Standard Error 0.22 | units on a scale | |
| Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks | BDP HFA 320 µg/Day | -2.9 | Standard Error 0.11 | units on a scale | |
| Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks | Placebo | -2.0 | Standard Error 0.21 | units on a scale | |
| Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks | BDP HFA 320 µg/Day | -3.7 | Standard Error 0.12 | units on a scale | |
| Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks | Placebo | -2.6 | Standard Error 0.23 | units on a scale | |
| Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks | BDP HFA 320 µg/Day | -3.1 | Standard Error 0.11 | units on a scale | |
| Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks | Placebo | -2.0 | Standard Error 0.22 | units on a scale | |
| Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | BDP HFA 320 µg/Day | -2.2 | Standard Error 0.09 | units on a scale | |
| Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | Placebo | -1.9 | Standard Error 0.19 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant 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 | 418 | |
| Overall Study | STARTED | Placebo | 111 | |
| Overall Study | Safety Population | BDP HFA 320 µg/Day | 415 | |
| Overall Study | Safety Population | Placebo | 111 | |
| Overall Study | Intent to Treat Population | BDP HFA 320 µg/Day | 414 | |
| Overall Study | Intent to Treat Population | Placebo | 110 | |
| Overall Study | COMPLETED | BDP HFA 320 µg/Day | 335 | |
| Overall Study | COMPLETED | Placebo | 85 | |
| Overall Study | NOT COMPLETED | BDP HFA 320 µg/Day | 83 | |
| Overall Study | NOT COMPLETED | Placebo | 26 |
Source ClinicalTrials.gov
Adverse events38
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 | Nasopharyngitis | Infections and infestations | BDP HFA 320 µg/Day | 67 | 415 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 14 | 111 | |
| other | Sinusitis | Infections and infestations | BDP HFA 320 µg/Day | 34 | 415 | |
| other | Sinusitis | Infections and infestations | Placebo | 8 | 111 | |
| other | Upper respiratory tract infection | Infections and infestations | BDP HFA 320 µg/Day | 43 | 415 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 7 | 111 | |
| other | Headache | Nervous system disorders | BDP HFA 320 µg/Day | 28 | 415 | |
| other | Headache | Nervous system disorders | Placebo | 6 | 111 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | BDP HFA 320 µg/Day | 44 | 415 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 111 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse 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 | 216 | 415 |
| Total, other adverse events | Placebo | 37 | 111 |
| Total, serious adverse events | BDP HFA 320 µg/Day | 8 | 415 |
| Total, serious adverse events | Placebo | 3 | 111 |
Source ClinicalTrials.gov
Papers2
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/NCT00988247
GET https://conductscience.org/api/trials/v1/NCT00988247/events?page=2