Trial · NCT02246920
Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
NCT02246920, Phase 3, Terminated, Teva Pharmaceuticals USA; results first posted 2023-06-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients. Trials, record NCT02246920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02246920
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
- NCT number
- NCT02246920
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,474 participants, actual
- Lead sponsor
- Teva Pharmaceuticals USA
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Fluticasone propionate, Flonase®, Placebo
- First posted
- 2014-09-23
- Last updated
- 2023-06-08
- Results first posted
- 2023-06-08
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/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. | 2 week treatment period: Day 0-14 | Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing. The primary analysis for determining the therapeutic equivalence of the Test and Reference treatments will be based on each treatment's mean change from baseline for average rTNSS over the 2 week randomization treatment period. The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence. The Modified Intent to Treat Population (mITT) will be used for Superiority Analysis. |
| Secondary | Change From Baseline in Average Instantaneous Total Nasal Symptom Score (iTNSS) Over Days 1 to 14. | 2 week treatment period: Day 0 to Day 14 | Secondary efficacy analysis will evaluate the mean change from baseline in average iTNSS over the 2 week randomization treatment period. The Per-Protocol Population (PPP) will be used for the analysis of bioequivalence. Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing. |
| Other | Superiority to Placebo | 2 week treatment period: Day 0 to Day 14 | The primary analysis for determining the superiority of each active treatment over placebo will be based on each treatment's mean change from baseline for average rTNSS over the 2 week randomization treatment period. The modified Intent-to-Treat Population (mITT) will be used for the primary analysis of superiority. Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing. |
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/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. | 2 week treatment period: Day 0-14 | Per Protocol Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Instantaneous Total Nasal Symptom Score (iTNSS) Over Days 1 to 14. | 2 week treatment period: Day 0 to Day 14 | Per Protocol Population | score on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Superiority to Placebo | 2 week treatment period: Day 0 to Day 14 | Modified Intent to Treat | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group9
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/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. | Investigational Test Product | -1.77 | Standard Error 0.11 | score on a scale | |
| Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. | Reference Listed Drug | -1.57 | Standard Error 0.10 | score on a scale | |
| Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. | Placebo | -1.26 | Standard Error 0.15 | score on a scale | |
| Change From Baseline in Average Instantaneous Total Nasal Symptom Score (iTNSS) Over Days 1 to 14. | Investigational Test Product | -1.70 | Standard Error 0.11 | score on a scale | |
| Change From Baseline in Average Instantaneous Total Nasal Symptom Score (iTNSS) Over Days 1 to 14. | Reference Listed Drug | -1.53 | Standard Error 0.11 | score on a scale | |
| Change From Baseline in Average Instantaneous Total Nasal Symptom Score (iTNSS) Over Days 1 to 14. | Placebo | -1.15 | Standard Error 0.15 | score on a scale | |
| Superiority to Placebo | Investigational Test Product | -1.77 | Standard Error 0.11 | score on a scale | |
| Superiority to Placebo | Reference Listed Drug | -1.57 | Standard Error 0.10 | score on a scale | |
| Superiority to Placebo | Placebo | -1.26 | Standard Error 0.15 | score on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Investigational Test Product | 484 | |
| Overall Study | STARTED | Reference Listed Drug | 460 | |
| Overall Study | STARTED | Placebo | 234 | |
| Overall Study | COMPLETED | Investigational Test Product | 477 | |
| Overall Study | COMPLETED | Reference Listed Drug | 453 | |
| Overall Study | COMPLETED | Placebo | 231 | |
| Overall Study | NOT COMPLETED | Investigational Test Product | 7 | |
| Overall Study | NOT COMPLETED | Reference Listed Drug | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events12
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 |
|---|---|---|---|---|---|---|
| serious | Concussion | Injury, poisoning and procedural complications | Investigational Test Product | 1 | 484 | 1 |
| serious | Concussion | Injury, poisoning and procedural complications | Reference Listed Drug | 0 | 460 | 0 |
| serious | Concussion | Injury, poisoning and procedural complications | Placebo | 0 | 234 | 0 |
| serious | Rib Fracture | Injury, poisoning and procedural complications | Investigational Test Product | 1 | 484 | 1 |
| serious | Rib Fracture | Injury, poisoning and procedural complications | Reference Listed Drug | 0 | 460 | 0 |
| serious | Rib Fracture | Injury, poisoning and procedural complications | Placebo | 0 | 234 | 0 |
| serious | Conversion disorder | Psychiatric disorders | Investigational Test Product | 1 | 484 | 1 |
| serious | Conversion disorder | Psychiatric disorders | Reference Listed Drug | 0 | 460 | 0 |
| serious | Conversion disorder | Psychiatric disorders | Placebo | 0 | 234 | 0 |
| serious | Pneumothorax | Respiratory, thoracic and mediastinal disorders | Investigational Test Product | 1 | 484 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Investigational Test Product | 0 | 484 |
| Total, all-cause mortality | Reference Listed Drug | 0 | 460 |
| Total, all-cause mortality | Placebo | 0 | 234 |
| Total, other adverse events | Investigational Test Product | 0 | 484 |
| Total, other adverse events | Reference Listed Drug | 0 | 460 |
| Total, other adverse events | Placebo | 0 | 234 |
| Total, serious adverse events | Investigational Test Product | 2 | 484 |
| Total, serious adverse events | Reference Listed Drug | 0 | 460 |
| Total, serious adverse events | Placebo | 0 | 234 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02246920
GET https://conductscience.org/api/trials/v1/NCT02246920/registered