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Clinical trials for Intranasal

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
    Study title: Intranasal and subcutaneous treatment of central precocious puberty in both sexes with a long-acting analog of luteinizing hormone-releasing hormoneIntranasal and subcutaneous treatment of central precocious puberty in both sexes with a long-acting analog of luteinizing hormone-releasing hormone - A.S. Luder et al. - 1984 (J. Clin. Endocrinol. Metab. ; 58: 966)
    Active substance: Buserelin
    Study summary document link (including results): Buserelin STUDY Luder 1984.xls
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    Document reference: 41850
    Study title: Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis. Meltzer EO. Ann Allergy Asthma Immunol. 1998 Aug;81(2):128-34.Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis. Meltzer EO. Ann Allergy Asthma Immunol. 1998 Aug;81(2):128-34.
    Active substance: BUDESONIDE
    Study summary document link (including results): Clinical and antiinflammatory effects of intranasal budesoni.pdf
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    Document reference: 45090
    Study title: A comparison of the efficacy and tolerability of budesonide given intranasally as a dry powder (via Turbuhaler) to placebo in children with seasonal allergic rhinitis.
    Active substance: BUDESONIDE
    Study summary document link (including results): 05-3003 Study Synopsis.pdf
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    Document reference: 22969
    Study title: A comparison of the efficacy and tolerability of budesonide given intranasally as a dry powder (via Turbuhaler) to placebo in children with seasonal allergic rhinitis.
    Active substance: BUDESONIDE
    Study summary document link (including results): 05-2172 Study Synopsis.pdf
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    Document reference: 22985
    Study title: Single Dose Pharmacokinetics of Intranasal Budesonide (Rhinocort Aqua®) in 2-5 Year-Old Children with Allergic Rhinitis.
    Active substance: BUDESONIDE
    Study summary document link (including results): D5360C03043 Study Synopsis.pdf
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    Document reference: 22978
    Study title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Long-term Treatment with RHINOCORT AQUA (budesonide) Nasal Spray in Children with Perennial Allergic Rhinitis. Single Dose Pharmacokinetics of Intranasal Budesonide (Rhinocort Aqua®) in 2-5 Year-Old Children with Allergic Rhinitis.
    Active substance: BUDESONIDE
    Study summary document link (including results): D5360C03043 Study Synopsis.pdf
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    Document reference: 22966
    Study title: Lahat E, Goldman M, Barr J, Bistritzer T, Berkovitch M. Comparison of intranasal midazolam with intravenous diazepam for treating febrile seizures in children: prospective randomised study. BMJ. 2000 Jul 8;321(7253):83-6.Lahat E, Goldman M, Barr J, Bistritzer T, Berkovitch M. Comparison of intranasal midazolam with intravenous diazepam for treating febrile seizures in children: prospective randomised study. BMJ. 2000 Jul 8;321(7253):83-6.
    Active substance: DIAZEPAM
    Study summary document link (including results):
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    Document reference: 25946
    Study title: Mahmoudian T, Zadeh MM. Comparison of intranasal midazolam with intravenous diazepam for treating acute seizures in children. Epilepsy Behav. 2004 Apr;5(2):253-5.Mahmoudian T, Zadeh MM. Comparison of intranasal midazolam with intravenous diazepam for treating acute seizures in children. Epilepsy Behav. 2004 Apr;5(2):253-5.
    Active substance: DIAZEPAM
    Study summary document link (including results):
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    Document reference: 25942
    Study title: Efficacy and safety of intranasally applied dimetindene maleate solution. Bauer, C.P. and Unkauf, M. (2001) Drug. Res. 51 (1), 232-237 Efficacy and safety of intranasally applied dimetindene maleate solution. Bauer, C.P. and Unkauf, M. (2001) Drug. Res. 51 (1), 232-237
    Active substance: DIMETINDENE
    Study summary document link (including results):
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    Document reference: 26163
    Study title: A multicenter, double-blind, randomized, placebo-controlled study to compare concomitant Montelukast and Loratadine with intranasal Beclomethasone in patients with seasonal allergic rhinitis
    Active substance: MONTELUKAST
    Study summary document link (including results):
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    Document reference: 32418
    Study title: Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study.
    Active substance: HYDROXYZINE
    Study summary document link (including results): ADPE96L1314.pdf
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    Document reference: 29285
    Study title: A double-blind, 2x2 Factohal Study to evaluate the effects of treatment with intranasal fluticasone propionate and use of Otovent mechanical ventilation of the middle ear on the need for surgery in children aged 4-8 with chronic or recurrent otitis media.
    Active substance: FLUTICASONE
    Study summary document link (including results): Study FLNL45-Fluticasone_Flixonase.xls
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    Document reference: 28363
    Study title: A placebo controlled trial during the pollen season comparing the effects of intranasal Beclomethasone dipropionate and intranasal Fluticasone propionate in children and young adults with asthma and allergic rhinitis.
    Active substance: FLUTICASONE
    Study summary document link (including results): Fluticasone-Propionate-FNM40054-ICHE3.pdf
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    Document reference: 28366
    Study title: Lack of effect of erythromycin and ketoconazole on the pharmacokinetics and pharmacodynamics of steady state intranasal levocabastine. Tran J Q, Di Cicco R A, Sheth S B, Tucci M, Peng L, Jorkasky D K, Hursting M J, Benincosa L J. Journal of clinical pharmacology, {May 1999, vol. 39, no. 5, p. 513 9.
    Active substance: ERYTHROMYCIN
    Study summary document link (including results):
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    Document reference: 26441
    Study title: Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996
    Active substance: SUFENTANYL
    Study summary document link (including results):
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    Document reference: 42622
    Study title: Ghigo E et al.: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. Journal of Clinical Endocrinology and Metabolism (J. CLIN. ENDOCRINOL. METAB. ) (United States) , May 24, 1991, 72/2 (467-470) Ghigo E et al.: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. Journal of Clinical Endocrinology and Metabolism (J. CLIN. ENDOCRINOL. METAB. ) (United States) , May 24, 1991, 72/2 (467-470)
    Active substance: NEOSTIGMINE
    Study summary document link (including results):
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    Document reference: 47052
    Study title: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children.Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children.
    Active substance: NEOSTIGMINE
    Study summary document link (including results):
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    Document reference: 47054
    Study title: Publication in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 Short-term growth in children with allergic rhinitis treated with oral antihistamine, depot and intranasal glucocorticoids - Wolthers OD - 1993 (Acta Paediatr 82:635-640)
    Active substance: TRIAMCINOLONE
    Study summary document link (including results):
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    Document reference: 46836
    Study title: Efficacy and safety of intranasally applied dimetindene maleate solution. Multicenter study in children under 14 years suffering from seasonal allergic rhinitisBauer 2001
    Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE
    Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Bauer_2001.xls
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    Document reference: 48026
    Study title: An Open-Label, Repeat Dose, Multicenter Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Intranasally Administered Triamcinolone Acetonide (Nasacort AQ) in Pediatric Allergic Rhinitis Patients 2 to 5 Years of Age Compared to Adult Patients 18 to 50 Years of Age
    Active substance: TRIAMCINOLONE
    Study summary document link (including results): Triamcinolone Acetonide-Study 2.pdf
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    Document reference: 46830
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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