Fluticasone Furoate
| Evidence Level: L4 | Predicted Indications: 8 |
Table of Contents
- Fluticasone Furoate
- Fluticasone Furoate: From Inhaled and Intranasal Corticosteroid Use to Atopic Eczema
Fluticasone Furoate: From Inhaled and Intranasal Corticosteroid Use to Atopic Eczema
One-Sentence Summary
Fluticasone furoate is a corticosteroid registered in South Africa in nasal spray and inhaler products. The registry data do not state its approved indications. The TxGNN model predicts it may be useful for atopic eczema, but the supporting evidence is weak: 10 supplied clinical trials (11 counted) and 2 publications, none of which tests fluticasone furoate in eczema.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the registry data (registered products are nasal sprays and inhalers) |
| Predicted New Indication | Atopic eczema |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 4 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Fluticasone furoate is a glucocorticoid, and glucocorticoids act through the glucocorticoid receptor to suppress inflammation. Mechanistically, this could apply to Th2-driven skin inflammation in eczema, and topical corticosteroids are already standard care for the condition.
This is a class effect, not a new repurposing signal. Every fluticasone-labelled eczema trial in the evidence uses fluticasone propionate, a different ester. No fluticasone furoate study in eczema was found. The very high TxGNN score most likely reflects the similarity of fluticasone drugs in the knowledge graph, not furoate-specific evidence.
The same prediction appears twice in the data, as “atopic eczema” and “dermatitis, atopic”. The two records share identical trials and literature and should be merged.
Clinical Trial Evidence
The table lists 10 of the 11 counted trials. Only 10 were supplied. None tests fluticasone furoate in eczema. No SANCTR or PACTR registrations were identified.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01772056 | Phase 3 | Terminated | 54 | Twice-weekly fluticasone propionate cream to prevent relapse in children with mild to moderate atopic dermatitis. Double-blind RCT, ended early. |
| NCT00546000 | Phase 4 | Completed | 56 | Cutivate (fluticasone propionate) lotion and its effect on the HPA axis in infants with atopic dermatitis. Open-label. |
| NCT01915914 | Phase 4 | Completed | 107 | Intermittent fluticasone propionate 0.05% cream plus moisturiser to reduce relapse in children. Open-label. |
| NCT00119158 | Phase 4 | Completed | 90 | Elidel cream combined with Cutivate cream in severe atopic dermatitis lesions. Double-blind, vehicle-controlled. |
| NCT03594565 | Early Phase 1 | Completed | 13 | Nasal steroids for skin reactions to glucose monitors in children with type 1 diabetes. The agent is not stated, and the condition is device-related. |
| NCT00690105 | Phase 4 | Completed | 577 | Tacrolimus 0.1% versus fluticasone 0.005% ointment in adults with facial atopic dermatitis. Fluticasone is the comparator. |
| NCT00689832 | Phase 4 | Completed | 487 | Tacrolimus 0.03% versus fluticasone 0.005% ointment in children with atopic dermatitis. Fluticasone is the comparator. |
| NCT00616538 | Phase 4 | Completed | 121 | EpiCeram barrier emulsion versus fluticasone propionate 0.05% in children. The steroid is the comparator. |
| NCT03742414 | Phase 2 | Active, not recruiting | 398 | Skin-barrier care plus fluticasone propionate cream to prevent eczema and food allergy in infants. |
| NCT00426283 | Phase 2 | Completed | 42 | Swallowed fluticasone propionate versus placebo, apparently in eosinophilic oesophagitis. Not an eczema trial. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 19571596 | 2009 | Review | Neuroimmunomodulation | Intranasal corticosteroids and adrenal suppression. It mentions that allergic rhinitis often coexists with atopic dermatitis, but it does not study eczema treatment. |
| 40066386 | 2025 | Case report | Indian J Otolaryngol Head Neck Surg | Allergen immunotherapy in a patient with autoimmune disease. It is only loosely related to this prediction. |
South Africa Market Information
| Registration Number | Product Name | Dosage Form |
|---|---|---|
| Reg. No. 41/21.5.1/0967 | Genemist | Spray |
| Reg. No. 41/21.5.1/0968 | Avamys 120 dose | Aqueous nasal spray |
| Reg. No. 48/21.5.1/0247 | Revinty Ellipta 92/22 µg | Inhaler |
| Reg. No. 52/21.5.1/0177 | Trelegy Ellipta | Inhaler |
The registry data give no approved-indication text for these products, so it should be confirmed against the current SAHPRA-approved labels. No topical (skin) fluticasone furoate product appears among the registrations.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
As class-level context, the retrieved material discusses HPA-axis (adrenal) suppression with corticosteroids, particularly in children. This is not a fluticasone furoate finding for eczema.
Conclusion and Next Steps
Decision: Hold
Rationale: The eczema prediction rests on a corticosteroid class effect and on trials of a different ester (fluticasone propionate). Topical corticosteroids are already standard eczema care, so this is not a novel repurposing signal. No furoate-specific eczema data were found, and no topical furoate product is registered in South Africa.
To proceed, the following is needed:
- Fluticasone furoate-specific efficacy and safety data in eczema.
- Merging of the duplicate “atopic eczema” and “dermatitis, atopic” records.
- The SAHPRA Professional Information (warnings and contraindications), which is a blocking gap for safety screening.
- Mechanism of action data from DrugBank.
- A route and formulation assessment, since registered products are intranasal or inhaled only.
Side note: the stronger direction in this Evidence Pack is bronchitis (chronic bronchitis and COPD), rated L2 with a “Proceed with Guardrails” recommendation. It has direct furoate evidence from the Relvar/Ellipta products (NCT03219255, NCT02989935), though these are observational or physiological studies and not efficacy trials. It would be better evaluated as a separate report.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.