Clinical trials: Pediatric Asthma
Asthma
Safety and Blood Level Study of Unit Dose Budesonide
The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.
- Trial name
- UDB P101 (NCT00627679)
- Testing
- Budesonide Inhalation Suspension, MAP0010 low dose, MAP0010 intermediate dose
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Allergan
Asthma
A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less…
- Trial name
- NCT05776927
- Testing
- QVM149, Salmeterol Xinafoate / Fluticasone Propionate
- Where
- 22 sites in Argentina, France and 7 more
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals
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
Wheezing, Reactive Airway Disease
A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma
The primary objective of this study is to evaluate budesonide levels in the blood following inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive airway disease or mild asthma using a…
- Conditions
- Wheezing, Reactive Airway Disease, Mild Asthma
- Trial name
- NCT03421730
- Testing
- VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System, 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Vectura Limited
Asthma
A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS
Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA
- Trial name
- NCT00400608
- Testing
- ADVAIR HFA, ADVAIR DISKUS
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
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
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.
Asthma
Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)
a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids
- Trial name
- NCT00832455
- Testing
- montelukast sodium
- Volunteers
- 445 people
- Sponsor
- Organon and Co
Asthma
4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma
This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA Inhalation Aerosol in comparison with the Active Control, Proventil-HFA (3M Pharmaceuticals, Inc) in pediatric patients (4-11 years old) with…
- Trial name
- NCT00634517
- Testing
- Armstrong Albuterol Sulfate Inhalation Aerosol, Albuterol Sulfate Inhalation Aerosol
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Asthma
GSK2190915 Pediatric Study
GSK2190915 is under development as an oral controller for the treatment of adult and pediatric asthma. This study is an open label, single and repeat dose escalation study, in children with asthma.
- Trial name
- NCT01286844
- Testing
- GSK2190915A 5mg, GSK2190915A 10mg, GSK2190915A 25mg
- Sponsor
- GlaxoSmithKline
Asthma
Inhaled Fluticasone Furoate/Vilanterol Safety and Tolerability, PK and PD Study
This study will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the novel dry powder inhaler in children aged 5 to 11 years…
- Trial name
- NCT01453023
- Testing
- Fluticasone Furoate, Fluticasone Furoate/Vilanterol
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- GlaxoSmithKline
Asthma, Bronchoconstriction
Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects
The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma
- Trial name
- NCT00685347
- Testing
- Levalbuterol HFA MDI, Racemic Albuterol
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- Sumitomo Pharma America, Inc.
Asthma
Asthma in Children
This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice.
- Trial name
- NCT01286532
- Where
- 11 sites in Russia
- Volunteers
- 283 people
- Sponsor
- AstraZeneca
Asthma in Children
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids
- Trial name
- NCT01658891
- Testing
- combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg, free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
- Where
- Denmark
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA DPI in Pediatric Subjects With Asthma
Asthma is a chronic inflammatory disease of airways and lungs that results in hyper-reactivity and clinically relevant episodes of wheezing.
- Trial name
- NCT03478657
- Testing
- ELLIPTA DPI, Ease of use questionnaires
- Where
- 19 sites in United States, Canada
- Volunteers
- 222 people
- Sponsor
- GlaxoSmithKline
Asthma
6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone…
- Trial name
- VESTRI (NCT01462344)
- Testing
- ADVAIR 100/50mcg, ADVAIR 250/50mcg, FLOVENT 100mcg
- Where
- 530 sites in United States, Argentina and 30 more
- Volunteers
- 6,250 people
- Sponsor
- GlaxoSmithKline
Asthma
Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients
This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with persistent asthma.
- Trial name
- NCT01899144
- Testing
- Albuterol Spiromax, ProAir HFA
- Where
- 22 sites in United States
- Volunteers
- 61 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Asthma
Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use
The primary objective of this study is to determine ex vivo the amount of fluticasone deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond Valved Holding Chamber (VHC) mouthpiece and the subject's…
- Trial name
- NCT01714063
- Testing
- Pressurized Metered-Dose Inhaler
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Philips Respironics
Asthma, Asthma in Children
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.
- Trial name
- NCT04450108
- Testing
- Vivatmo pro FeNO Test
- Where
- 6 sites in United States
- Volunteers
- 122 people
- Sponsor
- Bosch Healthcare Solutions GmbH
Bronchial Asthma
Fasenra Pediatric Japan Post-Marketing Study(PMS)
The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra). 1.
- Trial name
- NCT06427876
- Where
- 9 sites in Japan
- Volunteers
- 40 people
- Sponsor
- AstraZeneca