Clinical trials: Pediatric Respiratory Diseases
Asthma
Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma
The primary objective of this study is to compare the pharmacokinetic (PK) profiles of Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg albuterol base from each product.
- Trial name
- NCT01844401
- Testing
- Albuterol Spiromax®, ProAir® HFA
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Otitis Media, Infections, Respiratory Tract
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses.
- Conditions
- Otitis Media, Infections, Respiratory Tract, Respiratory Tract Infections
- Trial name
- NCT04600752
- Testing
- Augmentin (ES)-600
- Where
- 13 sites in India
- Volunteers
- 310 people
- Sponsor
- GlaxoSmithKline
Hay Fever, Perennial Allergic Rhinitis
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.
- Trial name
- NCT00261287
- Testing
- Ciclesonide
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- AstraZeneca
Influenza
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
- Trial name
- NCT00972816
- Testing
- MF59-eH1N1
- Where
- 35 sites in United States, Mexico
- Volunteers
- 1,357 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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
Rhinitis
Phenylephrine Pediatric Pharmacokinetic Study
To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to <12 years, and adolescents, ages 12 to <18 years.
- Trial name
- NCT00762567
- Testing
- phenylephrine HCl
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
Asthma
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
This study will be conducted to evaluate the effect of once daily treatment with fluticasone furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using knemometry.
- Trial name
- NCT02502734
- Testing
- Fluticasone furoate, Salbutamol
- Where
- Denmark
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Infections, Community Acquired Pneumonia
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
- Trial name
- NCT01530763
- Testing
- Ceftaroline fosamil, Ceftriaxone, amoxicillin clavulanate
- Where
- 44 sites in United States, Argentina and 7 more
- Volunteers
- 161 people
- Sponsor
- Forest Laboratories
Sleep Apnea, Sleep Apnea Syndromes in Children
Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations
The goal of this single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight…
- Conditions
- Sleep Apnea, Sleep Apnea Syndromes in Children, Sleep Apnea Syndromes
- Trial name
- NCT06218186
- Testing
- Medical Device: Wesper Lab Home Sleep Test
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Wesper Inc
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.
Pneumococcal Vaccines
Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant…
- Trial name
- NCT05844423
- Testing
- 0.5 ml dose of 1.1 mcg VAX-24, 0.5 ml dose of PCV20, 0.5 ml dose of 2.2 mcg VAX-24
- Where
- 32 sites in United States
- Volunteers
- 802 people, healthy volunteers welcome
- Sponsor
- Vaxcyte, Inc.
Asthma
Pediatric Ease of Use ELLIPTA Items
A range of devices has been developed to administer inhaled therapy for asthma, including dry powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat asthmatic subjects.
- Trial name
- NCT03315572
- Testing
- Interviewer administered version of ease of use items, Self-administered version of ease of use items, Caregiver version of ease of use items
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
Influenza, Human
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2016/2017 Quadrivalent Influenza Vaccine…
- Trial name
- NCT02914275
- Testing
- Seqirus Quadrivalent Inactivated Influenza Vaccine, Comparator Quadrivalent Inactivated Influenza Vaccine
- Where
- 39 sites in United States
- Volunteers
- 2,250 people, healthy volunteers welcome
- Sponsor
- Seqirus
Diphtheria, Tetanus
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01444781
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide, DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,106 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Severe Uncontrolled Asthma
PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma
This study will evaluate the PK, PD and long-term safety of Benralizumab administered subcutaneously in 30 children aged 6 to 11 years with severe eosinophilic asthma.
- Trial name
- TATE (NCT04305405)
- Testing
- Benralizumab
- Where
- 15 sites in United States, Japan
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Perennial Allergic Rhinitis
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.
- Trial name
- NCT01861522
- Testing
- Bepotastine besilate
- Where
- 2 sites in Japan
- Volunteers
- 473 people
- Sponsor
- Tanabe Pharma Corporation
RESPIRATORY SYNCYTIAL VIRUS (RSV)
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to <18 years of age.
- Trial name
- PICASSO (NCT05900154)
- Testing
- RSVpreF 120 µg, RSVpreF 60 µg
- Where
- 17 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Pfizer
Influenza
Study to Assess the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension
This study aims to evaluate the tolerability, safety, pharmacokinetic characteristics and efficacy of a single oral dose of GP681 powder for oral suspension in pediatric and adolescent patients with uncomplicated influenza.
- Trial name
- NCT06643156
- Testing
- GP681 10mg/20mg/40mg
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Influenza
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or…
- Trial name
- NCT00959049
- Testing
- CSL's Influenza Virus Vaccine (Afluria), Influenza Virus Vaccine (Fluzone)
- Where
- 23 sites in United States
- Volunteers
- 1,474 people, healthy volunteers welcome
- Sponsor
- Seqirus
Seasonal Allergic Rhinitis
A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
- Trial name
- NCT00968149
- Testing
- montelukast sodium
- Volunteers
- 413 people
- Sponsor
- Organon and Co