Clinical trials: Respiratory Disease of A Newborn
- Condition Respiratory Disease of A Newborn
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Cystic Fibrosis
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
- Trial name
- NCT04362761
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 29 sites in Australia, Belgium and 2 more
- Volunteers
- 172 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Cystic Fibrosis
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109…
- Trial name
- NCT02544451
- Testing
- LUM/IVA
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 246 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Mannitol Dose Response Study in Cystic Fibrosis
Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology…
- Trial name
- NCT00251056
- Testing
- mannitol
- Where
- 12 sites in Argentina, Canada
- Volunteers
- 48 people
- Sponsor
- Syntara
Respiratory Syncytial Virus
A Prospective, Epidemiological Study to Assess the Disease Burden of Respiratory Syncytial Virus Associated, Suspected Lower Respiratory Tract Infections in Newborns, From 0 to 2 Years of Age and Risk of Development of Wheeze and Asthma From 0 to 6 Years of Age
The purpose of this study is to assess the incidence and associated healthcare utilization of RSV-associated, suspected LRTI in a general population of infants from birth up to 2 years of age, and also to assess the accuracy of a…
- Trial name
- NCT01995175
- Testing
- Nasal swab sampling, Blood sampling, Diary cards
- Where
- 23 sites in United States, Argentina and 6 more
- Volunteers
- 2,409 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
- Trial name
- NCT00103714
- Testing
- denufosol tetrasodium (INS37217)
- Volunteers
- 72 people
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients
The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284 BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.
- Trial name
- NCT00060801
- Testing
- BIIL 283 BS (Amelubent)
- Where
- 35 sites in United States
- Volunteers
- 420 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis, Pancreatic Insufficiency
Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis
The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations) in children and adults with cystic fibrosis…
- Trial name
- NCT00432861
- Testing
- PANCRECARB® (pancrelipase)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Digestive Care, Inc.
Pancreatic Insufficiency, Cystic Fibrosis
Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
- Conditions
- Pancreatic Insufficiency, Cystic Fibrosis, Digestive System Diseases, Lung Diseases
- Trial name
- NCT01710644
- Testing
- Burlulipase
- Where
- 9 sites in United States
- Volunteers
- 35 people
- Sponsor
- Nordmark Arzneimittel GmbH & Co. KG
Cystic Fibrosis
A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation
Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance…
- Trial name
- NCT02516410
- Testing
- VX-661 plus ivacaftor combination, Ivacaftor
- Where
- 41 sites in United States, Australia and 5 more
- Volunteers
- 168 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Bronchopulmonary Dysplasia
129Xe MRI in Pediatric Population With BPD
Hyperpolarized (HP) gas magnetic resonance imaging (MRI) of the lungs offers additional information that cannot be obtained with CT scan, the current gold standard for imaging this disorder.
- Trial name
- NCT04035629
- Testing
- MagniXene, hyperpolarized 129Xe MRI
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Xemed LLC
Bronchopulmonary Dysplasia
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing…
- Trial name
- NCT01828957
- Testing
- Pneumostem®, Normal Saline
- Where
- 2 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- Medipost Co Ltd.
Cystic Fibrosis
Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age
The study evaluates the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF participants 2 to less than (<) 24 months of age.
- Trial name
- NCT05882357
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 19 sites in Australia, Canada and 5 more
- Volunteers
- 67 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
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
- NCT01180634
- Testing
- Aeroquin
- Where
- 112 sites in United States, Australia and 3 more
- Volunteers
- 330 people
- Sponsor
- Amgen
Pseudomonas Infection
Cipro Inhaler for Cystic Fibrosis Children Ages 6-12
Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation.
- Trial name
- NCT00910351
- Testing
- Ciprofloxacin (Cipro, BAYQ3939)
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- Bayer
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
Limb-Girdle Muscular Dystrophy, Type 2D
A Gene Transfer Therapy Study to Evaluate the Safety of SRP-9004 (Patidistrogene Bexoparvovec) in Participants With Limb-Girdle Muscular Dystrophy, Type 2D (LGMD2D)
This is an open-label, dose escalation gene transfer therapy study evaluating the safety of SRP-9004 (patidistrogene bexoparvovec) via isolated limb infusion (ILI) administration in approximately 6 participants with LGMD2D.
- Trial name
- NCT01976091
- Testing
- SRP-9004
- Volunteers
- 6 people
- Sponsor
- Sarepta Therapeutics, Inc.
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
Phase 2 Study to Assess the Safety and Efficacy of ANG003
In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI).
- Trial name
- NCT07450547
- Testing
- ANG003 Dose A, ANG003 Dose B, Creon
- Where
- 28 sites in United States
- Volunteers
- 113 people
- Sponsor
- Anagram Therapeutics, Inc.
Cystic Fibrosis
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR)…
- Trial name
- STRIVE (NCT00909532)
- Testing
- Ivacaftor
- Where
- 65 sites in United States, Australia and 6 more
- Volunteers
- 167 people
- Sponsor
- Vertex Pharmaceuticals Incorporated