Clinical trials: Pediatric Respiratory Diseases
Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis
Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children
Recurrent respiratory papillomatosis (RRP) is a rare disease in which wart-like growths caused by human papillomavirus (HPV) types 6 or 11 form in the airway.
- Conditions
- Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis, Papillomavirus Infections
- Trial name
- NCT07901738
- Testing
- Zopapogene imadenovec-drba
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Precigen, Inc
Influenza
Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza
This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.
- Trial name
- FROSTY (NCT02014649)
- Testing
- 20 mg laninamivir octanoate, 40 mg laninamivir octanoate
- Where
- 28 sites in United States
- Volunteers
- 15 people
- Sponsor
- Biota Scientific Management Pty Ltd
Asthma
FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following administration of fluticasone propionate HFA.
- Trial name
- NCT00370097
- Testing
- FLOVENT (fluticasone propionate) HFA
- Where
- 7 sites in United States
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Rhinitis, Allergic, Perennial, Hay Fever
To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)
The primary objective of this study is to demonstrate the safety of three dose levels of ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once daily, in pediatric patients (ages 2-5 years) with…
- Trial name
- NCT00658918
- Testing
- Ciclesonide nasal
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- AstraZeneca
Asthma
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the…
- Trial name
- NCT00328718
- Testing
- montelukast (5mg QD), Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
- Where
- 26 sites in Argentina, Colombia and 5 more
- Volunteers
- 526 people
- Sponsor
- GlaxoSmithKline
Rhinitis
Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics
To evaluate the safety of treatment with levocetirizine oral solution in pediatric patients aged form 6 months to 2 years old with allergic rhinitis or pruritus associated with the skin diseases.
- Trial name
- NCT01563081
- Testing
- Levocetirizine
- Where
- 7 sites in Japan
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Pulmonary Arterial Hypertension
FUTURE 3 Study Extension
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension…
- Trial name
- FUTURE 3 Ext (NCT01338415)
- Testing
- Bosentan
- Where
- 36 sites in United States, Australia and 16 more
- Volunteers
- 58 people
- Sponsor
- Actelion
COVID-19
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19
Phase 1 To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 2 To evaluate the…
- Trial name
- NCT04425629
- Testing
- casirivimab+imdevimab combination therapy
- Where
- 114 sites in United States, Mexico and 1 more
- Volunteers
- 10,078 people
- Sponsor
- Regeneron Pharmaceuticals
Nasal Congestion, Common Cold
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
The goal of this observational post-market clinical follow-up study is to evaluate the safety and performance of the CE-marked nasal spray for the relief of nasal congestion in infants and toddlers aged 6 to 48 months at day 5…
- Conditions
- Nasal Congestion, Common Cold, Allergic Rhinitis, Rhinosinusitis
- Trial name
- NASBY (NCT07257224)
- Testing
- Quinton Medical Nasal Health Baby®
- Where
- 2 sites in Spain
- Volunteers
- 83 people
- Sponsor
- Laboratoires Quinton International S.L.
Asthma
Advair Pediatric Once-Daily
To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.
- Trial name
- NCT00920959
- Testing
- FP 100mcg, FSC 100/50mcg
- Where
- 149 sites in United States, Argentina and 3 more
- Volunteers
- 908 people
- Sponsor
- GlaxoSmithKline
Nasal Polyps
Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)
The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old.
- Trial name
- NCT00378378
- Testing
- Mometasone Furoate Nasal Spray (MFNS)
- Volunteers
- 127 people
- Sponsor
- Organon and Co
Nosocomial Pneumonia
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
This is a phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia (NP).
- Trial name
- NCT04223752
- Testing
- Ceftolozane/Tazobactam
- Where
- 24 sites in United States, Chile and 7 more
- Volunteers
- 41 people
- Sponsor
- Merck Sharp & Dohme LLC
Urinary Tract Infections, Bacterial Pneumonia
Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)
This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia.
- Conditions
- Urinary Tract Infections, Bacterial Pneumonia, Soft Tissue Infections
- Trial name
- NCT00451386
- Testing
- MK0826, ertapenem sodium /Duration of Treatment: 14 Days, Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days
- Volunteers
- 400 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
Rhinitis, Allergic, Perennial
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis.
- Trial name
- NCT01135134
- Testing
- Mometasone furoate
- Volunteers
- 333 people
- Sponsor
- Organon and Co
Influenza
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated…
- Trial name
- NCT02369159
- Testing
- Peramivir, Oseltamivir
- Where
- 10 sites in United States, South Africa
- Volunteers
- 137 people
- Sponsor
- BioCryst Pharmaceuticals
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
Pediatric Bronchiolitis Obliterans
Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells
Bronchiolitis obliterans (BO) is a chronic lung disease which was initiated with injury of the bronchiolar epithelium and resulted in nonuniform luminal obliteration or narrowing.
- Trial name
- NCT07239895
- Testing
- Airway Basal Stem Cells
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Regend Therapeutics
Cystic Fibrosis
"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT00840333
- Testing
- MP-376 (Levofloxacin solution for Inhalation)
- Where
- 6 sites in United States
- Volunteers
- 27 people
- Sponsor
- Amgen
Acute Kidney Injury, Covid19
Renal Involvement in Hospitalized Children With COVID-19
Covid-19 is an important human and animal pathogen, it mostly causes respiratory and gastrointestinal symptoms. Clinical features range from a common cold to severe diseases such as severe acute respiratory distress syndrome…
- Conditions
- Acute Kidney Injury, Covid19, Renal Dysfunction, Coronavirus Infection
- Trial name
- RIHCC (NCT04788394)
- Testing
- data review, data comparing
- Where
- Qatar
- Volunteers
- 400 people
- Sponsor
- Hamad Medical Corporation