Clinical trials: Pediatric Pulmonary Disease
Medullary Thyroid Cancer, Infantile Myofibromatosis
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.
- Conditions
- Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer
- Trial name
- LIBRETTO-121 (NCT03899792)
- Testing
- Selpercatinib
- Where
- 26 sites in United States, Australia and 9 more
- Volunteers
- 36 people
- Sponsor
- Eli Lilly and Company
Asthma
Pharmacokinetics and PharmacoDynamics of GW685698 in Paedeatric Asthmatic Patients
This study will investigate the effect of dosing with flutucasone furoate in asthmatic subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over a 14 day treatment period, it will investigate…
- Trial name
- NCT01332292
- Testing
- Fluticasone furoate
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- GlaxoSmithKline
Asthma
Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
To investigate possible problems or questions in safety and efficacy of ADOAIR 100 DISKUS and ADOAIR 50 AEROSOL 120 in Japanese pediatric patients with bronchial asthma for a long term under the practical use conditions.
- Trial name
- NCT01332422
- Testing
- Salmeterol and Fluticasone
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Asthma
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- Trial name
- NCT03560466
- Testing
- Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies
- Where
- 81 sites in United States, Argentina and 16 more
- Volunteers
- 378 people
- Sponsor
- Sanofi
Asthma
Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma
This clinical study was designed to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed…
- Trial name
- NCT04589663
- Testing
- Mometasone furoate, QMF149, Standard of Care (Soc)
- Where
- 3 sites in Hungary, South Africa
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients
Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)
- Trial name
- NCT02269189
- Testing
- BIIL 284 BS, high dose, BIIL 284 BS, low dose
- Volunteers
- 36 people
- Sponsor
- Boehringer Ingelheim
Pneumonia, Pneumocystis Carinii, HIV Infections
A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening…
- Trial name
- NCT00002317
- Testing
- Trimetrexate glucuronate, Leucovorin calcium
- Where
- United States
- Sponsor
- U.S. Bioscience
Bronchial Asthma
Fasenra Pediatric Japan Post-Marketing Study(PMS)
The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra). 1.
- Trial name
- NCT06427876
- Where
- 9 sites in Japan
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Asthma
Albuterol HFA MDI in Pediatric Participants With Asthma
The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
- Trial name
- NCT00577655
- Testing
- Albuterol, Proventil® HFA
- Where
- 13 sites in United States
- Volunteers
- 103 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Pulmonary Arterial Hypertension
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.
- Trial name
- FUTURE 3 (NCT01223352)
- Testing
- bosentan
- Volunteers
- 64 people
- Sponsor
- Actelion
Aspergillosis, Invasive Pulmonary Aspergillosis
Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.
- Conditions
- Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis
- Trial name
- NCT01188759
- Testing
- Voriconazole, Anidulafungin
- Sponsor
- Pfizer
SARS-CoV-2, COVID-19
Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years
The purpose of this post-marketing study is to assess the safety of Comirnaty monovalent XBB.1.5. for booster vaccination children ages 6 months though 4 years under actual use medical practice.
- Trial name
- NCT06130410
- Testing
- COMIRNATY intramuscular injection
- Where
- Japan
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
RV - Right Ventricular Abnormality, LV Dysfunction
Pediatric Ventricle Function Assessment Study
This study aims to develop a deep learning-based framework for right ventricular (RV) segmentation, prediction of RV fractional area change (FAC), and identification of pediatric RV dysfunction.
- Conditions
- RV - Right Ventricular Abnormality, LV Dysfunction, Pulmonary Hypertension, TOF
- Trial name
- NCT06739057
- Where
- United States
- Volunteers
- 3,993 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Hypertension, Pulmonary
Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)
To describe the prevalence, incidence and current treatment and procedures patterns in a US pediatric population with PAH in MarketScan database during the period 2010-2013
- Trial name
- NCT02576002
- Testing
- Assigned pulmonary hypertension medication
- Where
- United States
- Volunteers
- 2,691 people
- Sponsor
- Bayer
Pulmonary Arterial Hypertension
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=)…
- Trial name
- NCT03492177
- Testing
- selexipag (Uptravi)
- Where
- 34 sites in United States, Belarus and 14 more
- Volunteers
- 63 people
- Sponsor
- Actelion
Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.
- Trial name
- NCT04456439
- Testing
- Remestemcel-L, Hydrocortisone, Diphenhydramine
- Sponsor
- Mesoblast International Sàrl
Asthma
A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
- Trial name
- NCT00583947
- Testing
- arformoterol, levalbuterol
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- Sumitomo Pharma America, Inc.
Infections, Pneumonia
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)
This is a study of safety and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.
- Trial name
- NCT01669980
- Testing
- Ceftaroline fosamil, IV Ceftriaxone and Vancomycin
- Where
- 21 sites in United States, Argentina and 2 more
- Volunteers
- 40 people
- Sponsor
- Forest Laboratories
Covid19, Corona Virus Infection
A Study of Baricitinib (LY3009104) in Children With COVID-19
The purpose for this study is to determine if the study drug baricitinib is effective and safe in hospitalized pediatric participants with Coronavirus disease 2019 (COVID -19) and to confirm the dose.
- Trial name
- COV-BARRIER (NCT05074420)
- Testing
- Baricitinib
- Where
- 14 sites in United States, Brazil and 2 more
- Volunteers
- 6 people
- Sponsor
- Eli Lilly and Company
Asthma
Safety and Efficacy of Berodual® Inhaled Via Respimat® Compared to MDI (Metered Dose Inhaler) in Pediatric Patients With Asthma
Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol hydrobromide + 20 µg ipratropium bromide and 25 µg fenoterol hydrobromide + 10 µg ipratropium bromide, 1 puff t.i.d.) administered via…
- Trial name
- NCT02182505
- Testing
- Berodual® Respimat®, low dose, Berodual® Respimat®, high dose, Berodual® MDI
- Volunteers
- 535 people
- Sponsor
- Boehringer Ingelheim