Trial · NCT01697956
Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
NCT01697956, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2015-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR). Trials, record NCT01697956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01697956
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
- NCT number
- NCT01697956
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 99 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Allergic Rhinitis
- Interventions
- BDP, Placebo
- First posted
- 2012-10-02
- Last updated
- 2015-10-08
- Results first posted
- 2015-10-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment | Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration) | The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived. |
| Secondary | Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. |
| Secondary | Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. |
| Secondary | Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. |
| Secondary | Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. |
| Secondary | Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. |
| Secondary | Participants With Treatment-Emergent Adverse Events (AEs) | Day 1- week 10 | The intensity or severity of the AE was characterized as mild (AE which is easily tolerated), moderate (AE sufficiently discomforting to interfere with daily activity) or severe (AE which prevents normal daily activities). The causal relationship was characterized as not related (no reasonable possibility that the AE was caused by or attributed to the investigational product) or related reasonable possibility that the AE was caused by or attributed to the investigational product / a causal relationship cannot be ruled out). An SAE was defined as an AE that resulted in any of the following: * Death * Life-threatening * Required hospitalization or prolonged existing hospitalization * Persistent or significant disability or incapacity * A congenital abnormality or birth defect * An important medical event which required medical intervention to prevent any of the above outcomes. |
| Secondary | Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study | Screening (Day -21 to -7), End of Study (Day 42) | Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study. MCHC = mean corpuscular hemoglobin concentration MCV = mean corpuscular volume, or mean cell volume MCH = mean corpuscular hemoglobin or mean cell hemoglobin |
| Secondary | Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study | Screening (Day -21 to -7), End of Study (Day 42) | Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study. BUN = blood urea nitrogen AST = aspartate transaminase ALT = alanine transaminase GGT = gamma-glutamyl transpeptidase |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment | Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration) | Per protocol (PP) population | ratio | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day | h*pg/mL | MEAN |
| SECONDARY | Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time. | h*pg/mL | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. | pg/mL | MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time. | hours | MEAN |
| SECONDARY | Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, λz for BDP could not be estimated for any participants. | 1/hour | MEAN |
| SECONDARY | Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP) | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, t1/2 for BDP could not be estimated for any participants. | hours | MEAN |
| SECONDARY | Participants With Treatment-Emergent Adverse Events (AEs) | Day 1- week 10 | Safety population which included all randomized participants who received at least one dose of randomized study medication. | participants | NUMBER |
| SECONDARY | Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study | Screening (Day -21 to -7), End of Study (Day 42) | Safety population | participants | NUMBER |
| SECONDARY | Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study | Screening (Day -21 to -7), End of Study (Day 42) | Safety population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group150
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment | BDP Nasal Aerosol 80 mcg/Day | 1.04 | Standard Error 1.037 | ratio | |
| Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment | Placebo Nasal Aerosol | 1.10 | Standard Error 1.053 | ratio | |
| Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | 17-BMP Pharmacokinetic Parameters | 573.81 | Standard Deviation 508.727 | h*pg/mL | |
| Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | BDP Pharmacokinetic Parameters | 45.60 | Standard Deviation 59.037 | h*pg/mL | |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | 17-BMP Pharmacokinetic Parameters | 619.06 | Standard Deviation 416.035 | h*pg/mL | |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | BDP Pharmacokinetic Parameters | 200.80 | Standard Deviation 69.939 | h*pg/mL | |
| Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | 17-BMP Pharmacokinetic Parameters | 142.68 | Standard Deviation 77.728 | pg/mL | |
| Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | BDP Pharmacokinetic Parameters | 44.65 | Standard Deviation 36.454 | pg/mL | |
| Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | 17-BMP Pharmacokinetic Parameters | 1.15 | Standard Deviation 1.189 | hours | |
| Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | BDP Pharmacokinetic Parameters | 1.26 | Standard Deviation 3.590 | hours |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BDP Nasal Aerosol 80 mcg/Day | 67 | |
| Overall Study | STARTED | Placebo Nasal Aerosol | 32 | |
| Overall Study | Per Protocol Population | BDP Nasal Aerosol 80 mcg/Day | 66 | |
| Overall Study | Per Protocol Population | Placebo Nasal Aerosol | 31 | |
| Overall Study | COMPLETED | BDP Nasal Aerosol 80 mcg/Day | 66 | |
| Overall Study | COMPLETED | Placebo Nasal Aerosol | 31 | |
| Overall Study | NOT COMPLETED | BDP Nasal Aerosol 80 mcg/Day | 1 | |
| Overall Study | NOT COMPLETED | Placebo Nasal Aerosol | 1 |
Source ClinicalTrials.gov
Adverse events8
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 | Epistaxis | Respiratory, thoracic and mediastinal disorders | BDP Nasal Aerosol 80 mcg/Day | 5 | 67 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo Nasal Aerosol | 1 | 32 | |
| other | Pyrexia | General disorders | BDP Nasal Aerosol 80 mcg/Day | 5 | 67 | |
| other | Pyrexia | General disorders | Placebo Nasal Aerosol | 1 | 32 | |
| other | Upper respiratory tract infection | Infections and infestations | BDP Nasal Aerosol 80 mcg/Day | 1 | 67 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Nasal Aerosol | 2 | 32 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | BDP Nasal Aerosol 80 mcg/Day | 0 | 67 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo Nasal Aerosol | 2 | 32 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BDP Nasal Aerosol 80 mcg/Day | ||
| Total, all-cause mortality | Placebo Nasal Aerosol | ||
| Total, other adverse events | BDP Nasal Aerosol 80 mcg/Day | 11 | 67 |
| Total, other adverse events | Placebo Nasal Aerosol | 6 | 32 |
| Total, serious adverse events | BDP Nasal Aerosol 80 mcg/Day | 0 | 67 |
| Total, serious adverse events | Placebo Nasal Aerosol | 0 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26250771 | 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 Nasal Aerosol 80 mcg/Day vs Placebo Nasal Aerosol: 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.
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