Phase 3
Completed N=727
A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Rhinitis, Allergic, Seasonal
Source: ClinicalTrials.gov NCT01279057 ↗
Enrolled (actual)
727
Serious AEs
0.1%
Results posted
Feb 2021
Primary outcomePrimary: PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population) — 2.036; 1.904 score on scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population) |
2.036; 1.904 | — |
| PRIMARY PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population) |
2.035; 1.845; 0.952 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population) |
2.017; 1.854 | — |
| SECONDARY Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population) |
1.994; 1.805; 0.846 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Equivalence: Per-Protocol Population) |
1.388; 1.152 | — |
| SECONDARY Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Superiority: Intent-to-Treat Population) |
1.373; 1.128; 0.787 | 0.0018 sig |
| SECONDARY Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Equivalence: Per-Protocol Population) |
1.389; 1.135 | — |
| SECONDARY Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Superiority: Intent-to-Treat Population) |
1.362; 1.118; 0.787 | 0.0018 sig |
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
- Signed informed consent (assent) form.
- Documented positive allergic skin test to local pollen.
- An average score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for "nasal congestion" and at least 4 on the reflective Total Ocular Symptom Score (rTOSS).
Exclusion Criteria
- History of asthma that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).
- Some other past and concomitant medical conditions, prohibited medications.
- Upper respiratory tract infection or any untreated infections.
- Patient has started immunotherapy/changed the dose.
- Any known allergy to any of the components of the study nasal spray.
Data sourced from ClinicalTrials.gov (NCT01279057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.