Trial · NCT01154153
Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis
NCT01154153, Phase 4, Completed, Sanofi; results first posted 2011-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis. Trials, record NCT01154153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01154153
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis
- NCT number
- NCT01154153
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 140 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Rhinitis, Allergic, Perennial and/or Seasonal
- Interventions
- Placebo nasal spray, Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ), Placebo nasal spray, Claritin® Syrup
- First posted
- 2010-06-30
- Last updated
- 2012-06-26
- Results first posted
- 2011-10-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline | 1-3 days prerandomization and 6 weeks postrandomization | Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times. Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC\[0-24 hr\] at 6 weeks postrandomization)/(Serum Cortisol AUC\[0-24 hr\] at 1-3 days prerandomization). Log transformation was used for the analysis. |
| Secondary | Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) | From 8-24 days prerandomization up to 6 weeks postrandomization | Every morning, participants rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms). Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase). |
| Secondary | Number of Participants by Relief Level as Evaluated by the Physician | At end of study (43-50 days after randomization) | Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present). |
| Secondary | Number of Participants by Relief Level as Evaluated by the Participant | At end of study (43-50 days after randomization) | Efficacy of treatment was assessed by the participant using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present). |
| Secondary | Number of Participants Using Rescue Medication | From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization) | The number of participants using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study). |
| Secondary | The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase | From randomization to 43-50 days postrandomization | The percent of days of rescue medication used during the double-blind treatment phase was calculated. For participants who did not use any rescue medication, the percentage of days using rescue medication was set to be 0. |
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 | Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline | 1-3 days prerandomization and 6 weeks postrandomization | The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) | From 8-24 days prerandomization up to 6 weeks postrandomization | The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples. | Score on a scale | MEAN |
| SECONDARY | Number of Participants by Relief Level as Evaluated by the Physician | At end of study (43-50 days after randomization) | The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples. | Participants | NUMBER |
| SECONDARY | Number of Participants by Relief Level as Evaluated by the Participant | At end of study (43-50 days after randomization) | The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples. | Participants | NUMBER |
| SECONDARY | Number of Participants Using Rescue Medication | From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization) | The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples. | Participants | NUMBER |
| SECONDARY | The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase | From randomization to 43-50 days postrandomization | The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples. | Percentage of days | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline | Placebo | 0.938 | Full Range 0.39 to 1.63 | Ratio | |
| Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline | TAA-AQ | 0.898 | Full Range 0.48 to 4.45 | Ratio | |
| Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) | Placebo | -0.22 | Standard Deviation 1.12 | Score on a scale | |
| Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) | TAA-AQ | -1.07 | Standard Deviation 1.66 | Score on a scale | |
| Number of Participants by Relief Level as Evaluated by the Physician | Placebo | Relief Level 0 (No relief) | 11 | Participants | |
| Number of Participants by Relief Level as Evaluated by the Physician | TAA-AQ | Relief Level 0 (No relief) | 9 | Participants | |
| Number of Participants by Relief Level as Evaluated by the Physician | Placebo | Relief Level 1 (Slight relief) | 18 | Participants | |
| Number of Participants by Relief Level as Evaluated by the Physician | TAA-AQ | Relief Level 1 (Slight relief) | 13 | Participants | |
| Number of Participants by Relief Level as Evaluated by the Physician | Placebo | Relief Level 2 (Moderate relief) | 16 | Participants | |
| Number of Participants by Relief Level as Evaluated by the Physician | TAA-AQ | Relief Level 2 (Moderate relief) | 20 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 71 | |
| Overall Study | STARTED | TAA-AQ | 69 | |
| Overall Study | COMPLETED | Placebo | 66 | |
| Overall Study | COMPLETED | TAA-AQ | 66 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | TAA-AQ | 3 |
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 | Headache | Nervous system disorders | Placebo | 4 | 71 | |
| other | Headache | Nervous system disorders | TAA-AQ | 2 | 69 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 7 | 71 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | TAA-AQ | 3 | 69 | |
| other | Pyrexia | General disorders | Placebo | 2 | 71 | |
| other | Pyrexia | General disorders | TAA-AQ | 4 | 69 | |
| serious | Humerus fracture | Injury, poisoning and procedural complications | Placebo | 1 | 71 | |
| serious | Humerus fracture | Injury, poisoning and procedural complications | TAA-AQ | 0 | 69 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | TAA-AQ | ||
| Total, other adverse events | Placebo | 12 | 71 |
| Total, other adverse events | TAA-AQ | 7 | 69 |
| Total, serious adverse events | Placebo | 1 | 71 |
| Total, serious adverse events | TAA-AQ | 0 | 69 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24717794 | 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 |
|---|
| TAA-AQ 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/NCT01154153
GET https://conductscience.org/api/trials/v1/NCT01154153/results?page=2