Beclomethasone Dipropionate
| Evidence Level: L3 | Predicted Indications: 1 |
Table of Contents
- Beclomethasone Dipropionate
- Beclomethasone Dipropionate: From Inhaled and Nasal Corticosteroid Products to Atopic Eczema
Beclomethasone Dipropionate: From Inhaled and Nasal Corticosteroid Products to Atopic Eczema
One-Sentence Summary
Beclomethasone dipropionate is a corticosteroid marketed in the US as metered aerosol products (for example QVAR REDIHALER and QNASL). The TxGNN model predicts it may be effective for atopic eczema. Support is limited: 0 registered clinical trials and 18 publications, of which only one is a small randomized trial (1984) and the rest are mostly older cohorts, reviews or preclinical studies.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Atopic eczema |
| TxGNN Prediction Score | 99.41% |
| Evidence Level | L3 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 10 |
| Recommended Decision | Hold |
The approved-indication text is empty in the source record, so the original indication is not listed. The marketed product forms (inhaled and nasal aerosols) are the only basis for the title.
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the record. Based on known information, beclomethasone dipropionate is a glucocorticoid receptor agonist. Corticosteroids as a class suppress pro-inflammatory cytokines and T-cell and eosinophil activity. This mechanism is inferred from drug class and has not been confirmed from the source record.
Atopic eczema is driven by type 2 inflammation, and corticosteroids are established therapy for it. The high TxGNN score fits this class-level logic.
Three caveats limit how far this reasoning goes:
- Route mismatch: The clinical literature covers oral or nasal beclomethasone, not the topical route normally used for eczema. The only US products in the record are metered aerosols.
- Weak study quality: The older positive studies are small, and their design and outcomes could not be fully verified from the truncated abstracts.
- Systemic exposure: Several papers report adrenal (HPA-axis) suppression and growth or bone-turnover concerns in children.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 6434024 | 1984 | RCT | Br Med J (Clin Res Ed) | Double-blind, placebo-controlled crossover trial in 26 children with severe atopic eczema. Four weeks of combined oral plus nasal beclomethasone improved eczema significantly more than placebo. 24-hour urinary cortisol excretion was slightly reduced. |
| 1476023 | 1992 | Cohort | Acta Derm Venereol Suppl | Oral beclomethasone in children with severe atopic dermatitis. Stable control in 10 of 14 patients at a mean dose of about 1000 µg/day. Growth and adrenal function were monitored, and the abstract reports evidence of slowed linear growth at this dose (text truncated). |
| 14522624 | 2003 | Cohort | J Dermatol Treat | Eight prepubertal children on steroid wet-wrap dressings. Short-term growth and bone turnover were assessed (results truncated in the record). |
| 30911861 | 2019 | Preclinical | AAPS PharmSciTech | Beclomethasone dipropionate mixed micelles in a hydrogel for dermal delivery, evaluated in a sub-chronic dermatitis animal model. Shows a possible route toward a topical formulation. |
| 19571596 | 2009 | Review | Neuroimmunomodulation | Review of intranasal corticosteroids and HPA-axis (adrenal) suppression in allergic disease, including patients with atopic dermatitis. |
| 11488426 | 2001 | Review | Jpn J Pharmacol | Glucocorticoids are described as the most efficacious drugs for allergic diseases. Beclomethasone dipropionate is used by inhalation. |
| 19874229 | 2009 | Preclinical (unclassified) | Immunopharmacol Immunotoxicol | In mice, mometasone furoate was more potent than beclomethasone dipropionate in an ear-edema model. Its oral systemic effects were lower than those of beclomethasone. |
| 9463794 | 1998 | Review (unclassified) | Drugs | Review of topical mometasone, a beclomethasone analogue. In atopic dermatitis its effects were similar to other potent steroids. Indirect evidence only. |
| 8765824 | 1996 | Not classified | J Allergy Clin Immunol | Topical steroids enhanced in vitro IgE production in atopic dermatitis patients. Suggests a possible drawback in severe disease. |
| 374799 | 1979 | Not classified | Nihon Hifuka Gakkai Zasshi | Comparative study of systemic effects of topical beclomethasone dipropionate versus betamethasone valerate ointment and fluocinonide cream. No abstract available, so findings are not verified. |
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| NDA207921 | QVAR REDIHALER | Aerosol, metered | Teva Respiratory, LLC (also repackaged by A-S Medication Solutions) |
| NDA202813 | QNASL | Aerosol, metered | Teva Respiratory, LLC |
| ANDA213811 | Beclomethasone Dipropionate | Aerosol, metered | Amneal Pharmaceuticals NY LLC |
Approved-indication text is not provided in the source record for any of these authorizations.
Safety Considerations
Please refer to the package insert for safety information. No drug-interaction data were found in the record.
Safety signals from the literature:
- Adrenal suppression: Slightly reduced 24-hour urinary cortisol in the 1984 trial. A review also describes HPA-axis effects of intranasal corticosteroids.
- Growth and bone turnover in children: Reported with oral beclomethasone at about 1000 µg/day and with occlusive steroid wet-wrap dressings.
- Corticosteroid hypersensitivity: A report on corticosteroid allergy in asthma patients (PMID 14616123) notes that corticosteroids can cause delayed contact allergy and, occasionally, immediate allergy.
Conclusion and Next Steps
Decision: Hold
Rationale: The TxGNN score is high and the class-level mechanism is plausible. However, there are no registered trials, and the only randomized evidence is a small 1984 crossover study using oral plus nasal dosing. Safety data are missing, and the marketed forms in the record are not topical.
To proceed, the following is needed:
- Package insert warnings and contraindications (blocking gap for safety screening)
- Confirmed mechanism of action from DrugBank
- Approved-indication text for the marketed products
- A route-compatibility assessment, since no topical or dermatologic form appears among the US products
- Full-text review of the older studies to verify design and outcomes
- Pediatric safety review covering HPA-axis, growth and bone turnover
- Prospective evidence, such as a controlled trial in atopic eczema, before any further advancement
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.