- Trials with a EudraCT protocol (1,312)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (57)

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: A placebo controlled dose-finding study with bambuterol in children with reversible obstructive airway disease.A multicentre study performedin Sweden. |
Active substance: BAMBUTEROL HYDROCHLORIDE |
Study summary document link (including results): 09-2017 Study Synopsis.pdf |
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Document reference: 46904 |
Study title: A single dose of bambuterol (Bambec) intravenous solution and tablets in patients with obstructive airway disease. |
Active substance: BAMBUTEROL HYDROCHLORIDE |
Study summary document link (including results): 09-2020 Study Synopsis.pdf |
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Document reference: 46905 |
Study title: A retrospective analysis of airway endoscopy in patients less than 1-month old. Ungkanont K. And al; Laryngoscope. 108(11 Pt 1):1724-8, 1998 Nov.A retrospective analysis of airway endoscopy in patients less than 1-month old. Ungkanont K. And al; Laryngoscope. 108(11 Pt 1):1724-8, 1998 Nov. |
Active substance: BARIUM SULPHATE |
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Document reference: 22126 |
Study title: Airway inflammation in patients with symptoms suggesting asthma but with normal lung function; Investigator initiated study: Publication: P. Rytilä et.al. Eur Respir J 2000; 16:824-830Airway inflammation in patients with symptoms suggesting asthma but with normal lung function; Investigator initiated study: Publication: P. Rytilä et.al. Eur Respir J 2000; 16:824-830 |
Active substance: BECLAMETHASONE |
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Document reference: 22235 |
Study title: Characterization of asymptomatic methacholine airway hyperresponsiveness (MAHR) in children: budesonide or placebo Turbuhaler treated |
Active substance: BUDESONIDE |
Study summary document link (including results): 04-9203 Study Synopsis.pdf |
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Document reference: 22932 |
Study title: Prophylactic treatment of wheezing in infants with hyper-reactive airways by oral Berotec solution. |
Active substance: FENOTEROL |
Study summary document link (including results): Fenoterol hydrobromide_U86-0413_synopsis.pdf |
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Document reference: 27094 |
Study title: Study on the obstruction in small airways. |
Active substance: FENOTEROL |
Study summary document link (including results): Fenoterol hydrobromide_U76-0596_synopsis.pdf |
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Document reference: 27060 |
Study title: Evaluation of optimal effective dose and action duration of ipratropium bromide in reducing bronchospasm in children with reversible chronic obstructive airway disease. |
Active substance: IPRATROPIUM |
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Document reference: 30549 |
Study title: Evaluation of optimal effective dose and action duration of ipratropium bromide in reducing bronchospasm in children with reversible chronic obstructive airway disease. |
Active substance: IPRATROPIUM |
Study summary document link (including results): Ipratropium bromide_U90-0054_synopsis.pdf |
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Document reference: 30699 |
Study title: Distribution of radioactive aerosol in the airways of children and adolescents with bronchial hyper-responsiveness. Backer V, Mortensen J. Clin Physiol. 1992 Sep;12(5):575-85. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48276 |
Study title: Piva JP, Menna Barreto SS, Zelmanovitz F, Amantea S, Cox P. Heliox versus oxygen for nebulized aerosol therapy in children with lower airway obstruction. Pediatr Crit Care Med 2002;3(1):6-10.Piva JP, Menna Barreto SS, Zelmanovitz F, Amantea S, Cox P. Heliox versus oxygen for nebulized aerosol therapy in children with lower airway obstruction. Pediatr Crit Care Med 2002;3(1):6-10. |
Active substance: HELIUM AND OXYGEN |
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Document reference: 29100 |
Study title: Sauder RA, Rafferty JF, Bilenki AL, Berkowitz ID. Helium-oxygen and conventional mechanical ventilation in the treatment of large airway obstruction and respiratory failure in an infant. South Med J 1991 May;84(5):646-8.Sauder RA, Rafferty JF, Bilenki AL, Berkowitz ID. Helium-oxygen and conventional mechanical ventilation in the treatment of large airway obstruction and respiratory failure in an infant. South Med J 1991 May;84(5):646-8. |
Active substance: HELIUM AND OXYGEN |
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Document reference: 29104 |
Study title: Smith SW, Biros M. Relief of imminent respiratory failure from upper airway obstruction by use of helium-oxygen: a case series and brief review. Acad Emerg Med 1999 Sep;6(9):953-6.Smith SW, Biros M. Relief of imminent respiratory failure from upper airway obstruction by use of helium-oxygen: a case series and brief review. Acad Emerg Med 1999 Sep;6(9):953-6. |
Active substance: HELIUM AND OXYGEN |
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Document reference: 29106 |
Study title: Ulhoa CAG, Larner L. Helium-oxygen (Heliox) mixture in airway obstruction. J Pediatr (Rio J) 2000 Jan-Feb;76(1):73-8.Ulhoa CAG, Larner L. Helium-oxygen (Heliox) mixture in airway obstruction. J Pediatr (Rio J) 2000 Jan-Feb;76(1):73-8. |
Active substance: HELIUM AND OXYGEN |
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Document reference: 29110 |
Study title: Curtis JL, Mahlmeister M, Fink JB, Lampe G, Matthay MA, Stulbarg MS. Helium-oxygen gas therapy. Use and availability for the emergency treatment of inoperable airway obstruction. Chest 1986 Sep;90(3):455-7.Curtis JL, Mahlmeister M, Fink JB, Lampe G, Matthay MA, Stulbarg MS. Helium-oxygen gas therapy. Use and availability for the emergency treatment of inoperable airway obstruction. Chest 1986 Sep;90(3):455-7. |
Active substance: HELIUM AND OXYGEN |
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Document reference: 29074 |
Study title: A multi-centre, randomised, double-blind, double-dummy, parallel-group study to determine the clinical equivalence between fluticasone propionate 50μg twice daily delivered via a multidose powder inhaler (MDPI) and the Diskhaler™ in children aged 4-11 years with reversible airways disease |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FMDT01-ICHE3.pdf |
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Document reference: 28432 |
Study title: Grosz AH, Jacobs IN, Cho C, Schears GJ. Use of helium-oxygen mixtures to relieve upper airway obstruction in a pediatric population. Laryngoscope 2001;111(9):1512-1514.Grosz AH, Jacobs IN, Cho C, Schears GJ. Use of helium-oxygen mixtures to relieve upper airway obstruction in a pediatric population. Laryngoscope 2001;111(9):1512-1514. |
Active substance: HELIUM AND OXYGEN |
Study summary document link (including results): |
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Document reference: 29081 |
Study title: Summary of the efficacy and safety and safety of salmeterol 50mcg and fluticasone propionate 100mcg administered in Diskus Dry Powder Inhaler twice daily in steroid experienced children with reversible airways obstruction |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40121-ICHE3.pdf |
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Document reference: 28449 |
Study title: DOUBLE-BLIND, 12-WEEK, PARALLEL-GROUP, MULTI-CENTRE TRIAL TO ASSESS FORMOTEROL DRY POWDER 12 UG AND 24 UG DAILY VS. SALBUTAMOL DRY POWDER 1200 UG DAILY IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASES |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 DP_PD2 Art45 listing 2011.xls |
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Document reference: 47832 |
Study title: Martinón-Torres F, Rodriguez-Nuñez A, Martinón-Sánchez JM. Nasal continuous positive airway pressure with heliox in infants with acute bronchiolitis. Respir Med 2006 Jan; Article in press.Martinón-Torres F, Rodriguez-Nuñez A, Martinón-Sánchez JM. Nasal continuous positive airway pressure with heliox in infants with acute bronchiolitis. Respir Med 2006 Jan; Article in press. |
Active substance: HELIUM AND OXYGEN |
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Document reference: 29093 |