Trial · NCT05692154
A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis
NCT05692154, Phase 3, Completed, Opella Healthcare Group SAS, a Sanofi Company; results first posted 2024-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis. Trials, record NCT05692154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05692154
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis
- NCT number
- NCT05692154
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 95 participants, actual
- Lead sponsor
- Opella Healthcare Group SAS, a Sanofi Company
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Fexofenadine, Placebo
- First posted
- 2023-01-20
- Last updated
- 2025-09-09
- Results first posted
- 2024-05-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3) | From 0 hour to 6 hours at Day 4 | TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC \[0-6 hr\]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.5; Arm B=2.1-39.9. |
| Secondary | AUC of Total Ocular Symptoms Score (TOSS) (H0-H6 at Day 4) | From 0 hour to 6 hours at Day 4 | TOSS=composite score calculated as the sum of red/burning eyes, tearing, itchy/watery eyes scores (TOSS: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. individual scores were collected in e-diary. AUC of TOSS from time of the first observation to time of the last observation (AUC \[0-6 hr\]) was calculated by using the linear trapezoid. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.6; Arm B=0.0-35.1. |
| Secondary | AUC of Total Nasal Symptoms Score (TNSS-3) (H0-H12 at Day 4) | From 0 hour to 12 hours at Day 4 | TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC \[0-12 hr\]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-63.5; Arm B=2.1-69.4. |
| Secondary | AUC of Total Ocular Symptoms Score (TOSS) (H0-H12 at Day 4) | From 0 hour to 12 hours at Day 4 | TOSS=composite score calculated as the sum of red/burning eyes, tearing, itchy/watery eyes scores (TOSS: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. individual scores were collected in e-diary. AUC of TOSS from time of the first observation to time of the last observation (AUC \[0-12 hr\]) was calculated by using the linear trapezoid. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-58.6; Arm B=0.0-65.5. |
| Secondary | AUC of Total Nasal Symptoms Score (TNSS-3) (Day 1 to Day 4) | From randomization (Day 1) to Day 4 | TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3:scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC \[Day 1 to Day 4\]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-267.8; Arm B=2.1-379.0. |
| Secondary | AUC of Total Ocular Symptoms Score (TOSS) (Day 1 to Day 4) | From randomization (Day 1) to Day 4 | TOSS=composite score calculated as the sum of red/burning eyes, tearing, itchy/watery eyes scores (TOSS: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. individual scores were collected in e-diary. AUC of TOSS from time of the first observation to time of the last observation (AUC \[Day 1 to Day 4\]) was calculated by using the linear trapezoid. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-226.6; Arm B=0.0-304.5. |
| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | From Day 2 to Day 5 | An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A treatment emergent adverse event (TEAE) is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3) | From 0 hour to 6 hours at Day 4 | The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4. | Sum of scores*hours | MEAN |
| SECONDARY | AUC of Total Ocular Symptoms Score (TOSS) (H0-H6 at Day 4) | From 0 hour to 6 hours at Day 4 | The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4. | Sum of scores*hours | MEAN |
| SECONDARY | AUC of Total Nasal Symptoms Score (TNSS-3) (H0-H12 at Day 4) | From 0 hour to 12 hours at Day 4 | The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4. | Sum of scores*hours | MEAN |
| SECONDARY | AUC of Total Ocular Symptoms Score (TOSS) (H0-H12 at Day 4) | From 0 hour to 12 hours at Day 4 | The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4. | Sum of scores*hours | MEAN |
| SECONDARY | AUC of Total Nasal Symptoms Score (TNSS-3) (Day 1 to Day 4) | From randomization (Day 1) to Day 4 | The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4. | Sum of scores*hours | MEAN |
| SECONDARY | AUC of Total Ocular Symptoms Score (TOSS) (Day 1 to Day 4) | From randomization (Day 1) to Day 4 | The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4. | Sum of scores*hours | MEAN |
| SECONDARY | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | From Day 2 to Day 5 | The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3) | Arm A (Active-active) | 16.96 | Standard Deviation 9.090 | Sum of scores*hours | |
| Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3) | Arm B (Placebo-active) | 21.42 | Standard Deviation 10.431 | Sum of scores*hours | |
| AUC of Total Ocular Symptoms Score (TOSS) (H0-H6 at Day 4) | Arm A (Active-active) | 11.74 | Standard Deviation 10.451 | Sum of scores*hours | |
| AUC of Total Ocular Symptoms Score (TOSS) (H0-H6 at Day 4) | Arm B (Placebo-active) | 16.21 | Standard Deviation 11.253 | Sum of scores*hours | |
| AUC of Total Nasal Symptoms Score (TNSS-3) (H0-H12 at Day 4) | Arm A (Active-active) | 23.66 | Standard Deviation 14.049 | Sum of scores*hours | |
| AUC of Total Nasal Symptoms Score (TNSS-3) (H0-H12 at Day 4) | Arm B (Placebo-active) | 31.01 | Standard Deviation 18.555 | Sum of scores*hours | |
| AUC of Total Ocular Symptoms Score (TOSS) (H0-H12 at Day 4) | Arm A (Active-active) | 14.74 | Standard Deviation 14.432 | Sum of scores*hours | |
| AUC of Total Ocular Symptoms Score (TOSS) (H0-H12 at Day 4) | Arm B (Placebo-active) | 21.67 | Standard Deviation 17.154 | Sum of scores*hours | |
| AUC of Total Nasal Symptoms Score (TNSS-3) (Day 1 to Day 4) | Arm A (Active-active) | 56.34 | Standard Deviation 55.697 | Sum of scores*hours | |
| AUC of Total Nasal Symptoms Score (TNSS-3) (Day 1 to Day 4) | Arm B (Placebo-active) | 65.48 | Standard Deviation 76.454 | Sum of scores*hours |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Active-active) | 47 | |
| Overall Study | STARTED | Arm B (Placebo-active) | 48 | |
| Overall Study | Intent To Treat (ITT) Analysis Set | Arm A (Active-active) | 47 | |
| Overall Study | Intent To Treat (ITT) Analysis Set | Arm B (Placebo-active) | 48 | |
| Overall Study | Safety Analysis (SAF) Set | Arm A (Active-active) | 47 | |
| Overall Study | Safety Analysis (SAF) Set | Arm B (Placebo-active) | 47 | |
| Overall Study | Modified Intent-to-Treat (mITT) Analysis Set | Arm A (Active-active) | 47 | |
| Overall Study | Modified Intent-to-Treat (mITT) Analysis Set | Arm B (Placebo-active) | 47 | |
| Overall Study | COMPLETED | Arm A (Active-active) | 47 | |
| Overall Study | COMPLETED | Arm B (Placebo-active) | 47 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
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 | Tinnitus | Ear and labyrinth disorders | Arm A (Active-active) | 0 | 47 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm B (Placebo-active) | 1 | 47 | |
| other | Oedema mucosal | General disorders | Arm A (Active-active) | 2 | 47 | |
| other | Oedema mucosal | General disorders | Arm B (Placebo-active) | 0 | 47 | |
| other | Seasonal allergy | Immune system disorders | Arm A (Active-active) | 1 | 47 | |
| other | Seasonal allergy | Immune system disorders | Arm B (Placebo-active) | 0 | 47 | |
| other | Gastroenteritis | Infections and infestations | Arm A (Active-active) | 0 | 47 | |
| other | Gastroenteritis | Infections and infestations | Arm B (Placebo-active) | 1 | 47 | |
| other | Skin abrasion | Injury, poisoning and procedural complications | Arm A (Active-active) | 1 | 47 | |
| other | Skin abrasion | Injury, poisoning and procedural complications | Arm B (Placebo-active) | 0 | 47 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Active-active) | 0 | 47 |
| Total, all-cause mortality | Arm B (Placebo-active) | 0 | 47 |
| Total, other adverse events | Arm A (Active-active) | 9 | 47 |
| Total, other adverse events | Arm B (Placebo-active) | 6 | 47 |
| Total, serious adverse events | Arm A (Active-active) | 0 | 47 |
| Total, serious adverse events | Arm B (Placebo-active) | 0 | 47 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Active-active) vs Arm B (Placebo-active): deaths from any cause | Trial comparisons |
| Arm A (Active-active) vs Arm B (Placebo-active): serious adverse events | 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/NCT05692154
GET https://conductscience.org/api/trials/v1/NCT05692154/events?page=2