Clinical trials: Pediatric Pulmonary Disease
Respiratory Distress Syndrome
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
- Trial name
- NCT00807235
- Testing
- Aerosolized lucinactant
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Windtree Therapeutics
Graft vs Host Disease
Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant
This open-label, single-arm, Phase II multi-center study enrolled 46 participants and investigated the activity, pharmacokinetics and safety of ruxolitinib added to the subject's immunosuppressive regimen among infants, children…
- Trial name
- REACH 5 (NCT03774082)
- Testing
- INC424
- Where
- 21 sites in Brazil, Canada and 12 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Coronavirus Disease 2019 (COVID-19)
A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19
A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination…
- Trial name
- ENDURE (NCT05375760)
- Testing
- AZD7442 (tixagevimab [AZD8895] + cilgavimab [AZD1061])
- Where
- 16 sites in United States
- Volunteers
- 251 people
- Sponsor
- AstraZeneca
Asthma
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler…
- Trial name
- NCT02040766
- Testing
- Beclomethasone dipropionate BAI, albuterol/salbutamol 90 mcg, Beclomethasone dipropionate MDI
- Where
- 102 sites in United States, Croatia and 3 more
- Volunteers
- 628 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Healthy Subjects
A Study to Explore the Physiological Impact of AIR+ KN95 Masks on Children
The primary objective is to evaluate the physiological impact of AIR+ KN95 Masks on end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age.
- Trial name
- NCT07037381
- Testing
- KN95 mask
- Where
- Singapore
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Innosparks Pte Ltd.
Asthma
Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
- Trial name
- NCT00073814
- Testing
- Levalbuterol tartrate MDI, racemic albuterol MDI
- Where
- 45 sites in United States
- Volunteers
- 80 people
- Sponsor
- Sumitomo Pharma America, Inc.
Asthma
Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma
The purpose of this study is to investigate the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency.
- Trial name
- NCT01584726
- Testing
- Magnesium Sulfate
- Where
- 2 sites in Qatar
- Volunteers
- 400 people
- Sponsor
- Hamad Medical Corporation
Hypertension, Pulmonary
Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months.
- Trial name
- NCT01342952
- Testing
- Ambrisentan
- Where
- 22 sites in United States, Argentina and 7 more
- Volunteers
- 38 people
- Sponsor
- GlaxoSmithKline
Hypertension, Pulmonary
Efficacy and Safety of Ambrisentan in Children 8-18yrs
A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in subjects aged 8 years up to 18 years with pulmonary…
- Trial name
- NCT01332331
- Testing
- Ambrisentan - low dose, Ambrisentan - high dose
- Where
- 24 sites in United States, Argentina and 7 more
- Volunteers
- 41 people
- Sponsor
- GlaxoSmithKline
Asthma
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
- Trial name
- NCT00943683
- Testing
- montelukast sodium
- Volunteers
- 256 people
- Sponsor
- Organon and Co
Chronic Graft Versus Host Disease
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)
- Trial name
- NCT03790332
- Testing
- Ibrutinib
- Where
- 48 sites in United States, Australia and 11 more
- Volunteers
- 59 people
- Sponsor
- Pharmacyclics LLC.
Cystic Fibrosis
Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation
The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR…
- Trial name
- NCT01946412
- Testing
- Ivacaftor
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 33 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Asthma
Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)
A clinical study explores the safety and efficacy of montelukast and to compare the safety and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients when they are used in conjunction with…
- Trial name
- NCT00756418
- Testing
- montelukast, Theophylline
- Volunteers
- 84 people
- Sponsor
- Organon and Co
SARS-CoV2 Infection
COVAXIN in a Pediatric Cohort
The study is designed to evaluate the safety, reactogenicity and immunogenicity of three groups ages ≤18 - >12, ≤12 ->6, ≤ 6 - >2 years of healthy volunteers who receive two doses of the whole virion inactivated SARS-CoV-2 virus…
- Trial name
- COVAXIN-Peds (NCT04918797)
- Testing
- COVAXIN
- Where
- 7 sites in India
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
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
SARS-CoV-2
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory…
- Trial name
- NCT06585241
- Testing
- mRNA-1273 Variant-containing Formulation
- Where
- 6 sites in United States
- Volunteers
- 1,144 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Asthma
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma.
- Trial name
- NCT00308685
- Testing
- Albuterol
- Where
- 14 sites in United States
- Volunteers
- 95 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Asthma
Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma
The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma
- Trial name
- NCT00684866
- Testing
- Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI, Racemic Albuterol followed by levalbuterol HFA MDI
- Where
- 11 sites in United States
- Volunteers
- 31 people
- Sponsor
- Sumitomo Pharma America, Inc.
Respiratory Syncytial Virus Bronchiolitis
Respiratory Syncytial Virus (RSV) Follow-Up Study (MK-0476-374)
This is a prospective, multicenter, observational study in participants who completed the 24-week, placebo-controlled MK-0476 Protocol 272 (NCT00076973) study of montelukast in the treatment of respiratory symptoms subsequent to…
- Trial name
- NCT01140048
- Volunteers
- 343 people
- Sponsor
- Organon and Co