Clinical trials: Cystic Fibrosis in Children
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Hypertonic Saline and Mucociliary Clearance in Children
Previously, the investigators and others have shown that mucociliary clearance (MCC) is defective in patients with cystic fibrosis (CF) and it is now thought that alterations in airway mucus rheology figure prominently in the…
- Trial name
- NCT01293084
- Testing
- 0.12% saline, 7% saline
- Volunteers
- 17 people
- Sponsor
- Johns Hopkins University
Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive
Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main…
- Trial name
- EPIC (NCT00097773)
- Testing
- Tobramycin solution for inhalation (TOBI), Oral ciprofloxacin
- Where
- 54 sites in United States
- Volunteers
- 304 people
- Sponsor
- Seattle Children's Hospital
Cystic Fibrosis
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution.
- Trial name
- ELITE (NCT00391976)
- Testing
- Tobramycin solution for inhalation 300 mg
- Volunteers
- 123 people
- Sponsor
- Novartis
Cystic Fibrosis, Pancreatic Insufficiency
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic…
- Trial name
- NCT00880100
- Testing
- Ultrase® MT12
- Where
- 15 sites in United States
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
Pharmacokinetics of Linezolid in Children With Cystic Fibrosis
To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.
- Trial name
- NCT00625703
- Testing
- Linezolid
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- University of Texas Southwestern Medical Center
Healthy, Cystic Fibrosis (CF)
MRI for Non-Invasive Imaging in Neonates and Children
The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent.
- Conditions
- Healthy, Cystic Fibrosis (CF), Asthma, Bronchopulmonary Dysplasia (BPD)
- Trial name
- NCT02163681
- Testing
- Hyperpolarized Helium-3 MRI of the chest
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Cystic Fibrosis
Effectiveness of Pulmozyme in Infants With Cystic Fibrosis
This is a study to find out whether Pulmozyme is effective for clearing mucus from the airways of children with cystic fibrosis less than 3 ½ years of age.
- Trial name
- NCT00179998
- Testing
- Recombinant Human DNase (Pulmozyme)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Nationwide Children's Hospital
Cystic Fibrosis
Effect of Glycine in Cystic Fibrosis
The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5 g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic fibrosis, as compared with placebo.
- Trial name
- NCT01417481
- Testing
- Glycine
- Where
- 3 sites in Mexico
- Volunteers
- 13 people
- Sponsor
- Instituto Nacional de Enfermedades Respiratorias
Cystic Fibrosis, Pneumonia
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation.
- Conditions
- Cystic Fibrosis, Pneumonia, Pseudomonas Aeruginosa Infection
- Trial name
- NCT01429259
- Testing
- meropenem
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Joseph Kuti
Cystic Fibrosis, Pancreatic Insufficiency
Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)
This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan).
- Trial name
- NCT00513682
- Testing
- Ultrase® MT20
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis
The investigators know that adherence to medications in children with cystic fibrosis (CF) is poor. Forgetfulness has often been reported as a barrier to adherence by both CF patients and their parents.
- Trial name
- NCT02301377
- Testing
- Spiro PD personal spirometer
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Michigan
Cystic Fibrosis
Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis
Previous work demonstrated that inhaled hypertonic saline (HS) reduces exacerbation frequency and improves lung function in adults with cystic fibrosis (CF).
- Trial name
- NCT01031706
- Testing
- Hypertonic Saline
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of North Carolina, Chapel Hill
Cystic Fibrosis
The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis
The purpose of this randomized, placebo-controlled (Phase II) study will be to further evaluate the effects of oral glutathione on growth in children with CF.
- Trial name
- GROW (NCT03020719)
- Testing
- Oral Glutathione
- Where
- 18 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Minnesota
Cystic Fibrosis, Pancreatic Exocrine Insufficiency
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
- Trial name
- NCT00775528
- Testing
- Pancrelipase Delayed Release
- Where
- 12 sites in United States
- Volunteers
- 19 people
- Sponsor
- Solvay Pharmaceuticals
Pancreatic Exocrine Insufficiency
Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.
- Trial name
- NCT01747330
- Testing
- Pancreatin
- Where
- 9 sites in Russia
- Volunteers
- 40 people
- Sponsor
- Abbott Products
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences