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Asthma clinical trials

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NCT ID: NCT01470755 Completed - Asthma Clinical Trials

Study of Dose-response to Bronchodilator and Dose-finding in Child 2.5 to 6 Years - Study Golden

DORESI
Start date: January 2012
Phase: Phase 2
Study type: Interventional

In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool children whose disease pathophysiology is poorly understood, but may, in part, takes on the characteristics of asthma. The investigators assume that 1) in young children interrupter resistance (Rint) could be used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the dose-response relationship could depend on the environment and gene polymorphism ADBR2. This is a prospective phase II study on dose-response relationship and description of the dose-response curve design using a "sparse" and a modeling approach MCP-Mod. The dose-response relationship will be modeled by sparse data. The investigators will test two doses per child in four designs that will be drawn. These doses will be assessed using Rint technique by a person blinded to the actual dose delivered to the child. Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with an accuracy of 3.5%, 8.9% and 25.7% respectively. The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA (No. 344 387-3)

NCT ID: NCT01468272 Completed - Asthma in Children Clinical Trials

Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old

PAED4
Start date: November 2011
Phase: Phase 2
Study type: Interventional

This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.

NCT ID: NCT01462617 Completed - Asthma Clinical Trials

Study to Investigate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Single & Repeat Doses of GSK2269557

Start date: July 24, 2011
Phase: Phase 1
Study type: Interventional

The study will comprise three Parts: Part A will consist of two cohorts of healthy male volunteers to assess the safety, tolerability and pharmacokinetics of ascending single doses of nebulised GSK2269557. Blinded safety and available PK data will be reviewed before each dose escalation. Part B will be one cohort to examine the safety, tolerability and pharmacokinetics of a repeated dose of GSK2269557 given by nebuliser for 7 days in healthy male volunteers. The total daily dose will be the same as, or lower than, doses that are well tolerated in Part A. Part C will consist of two cohorts of single nebulised doses in healthy male smokers, to assess pharmacodynamic endpoints in sputum and bronchoalveolar lavage.

NCT ID: NCT01462344 Completed - Asthma Clinical Trials

6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old

VESTRI
Start date: November 17, 2011
Phase: Phase 4
Study type: Interventional

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 propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

NCT ID: NCT01461642 Completed - Asthma Clinical Trials

E-support for Healthcare Processes - ASTHMA

E-ASTHMA
Start date: October 2011
Phase: N/A
Study type: Interventional

The purpose of the study is to establish and clinically evaluate a new approach to treating asthma by using information and communication technologies (ICT). A mobile environment, and organizational interventions to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated.

NCT ID: NCT01460511 Completed - Asthma Clinical Trials

Evaluation of Efficacy and Safety of E004 in Children With Asthma

Start date: October 2011
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo HFA-MDI in pediatric patients who are 4-11 years of age with asthma.

NCT ID: NCT01456494 Completed - Asthma Clinical Trials

Teaching Use of Respiratory Inhalers (TURI)

TURI
Start date: July 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility of enrolling and randomizing patients into one of two educational interventions to teach appropriate respiratory inhaler technique and to collect preliminary estimates of the comparative effectiveness of two types of education. Teach-to-Goal (TTG) education employs instruction followed by patient "teach-back," then repeated cycles of learning and assessment until a skill, i.e. respiratory inhaler technique, is mastered. By contrast, Brief Intervention (BI) education only consists of providing the patient with verbal and written instruction on the skill, i.e., respiratory inhaler technique. The investigators hypothesize that hospital-based TTG compared to BI increases a patient's ability to learn respiratory inhaler technique. The investigators will test this hypothesis separately for the MDI and Diskus® devices.

NCT ID: NCT01455545 Completed - Asthma Clinical Trials

Impact of Adherence to Treatment in Asthma Control

Start date: January 2011
Phase: N/A
Study type: Observational

This survey aims to analyze how adherence to treatment, using Ask-20 questionnaire and prescription count, influences level of asthma control in a sample of patients with severe and moderate-mild asthma.

NCT ID: NCT01455194 Completed - Bronchial Asthma Clinical Trials

Effect of High Dose Ciclesonide on Asthma Control

CONTRAST
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The aim of the trial is to investigate asthma control with 160 to 640 μg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).

NCT ID: NCT01453881 Completed - Asthma Clinical Trials

Fine Particle pMDI Formoterol/Beclomethasone in Asthmatics With and Without Spacer: Comparative Efficacy Evaluation

EFFECT-EV
Start date: April 2011
Phase: Phase 3
Study type: Interventional

Adequate pharmacological treatment controls symptoms in most asthmatics. Pressurized metered dose inhalers (pMDI)are the most used drug delivery devices. Valved holding chambers of different types and sizes have also been developed for use in combination with pMDI. The therapeutic efficacy of treatment depends on the amount of inhaled particles. The chambers can optimize lung deposition as it obviates lung-hand coordination and retain larger particles. The aim of this study is to compare the efficacy of the fine particle combination pMDI Beclomethasone/Formoterol in asthma control,with or without the aid of a spacer in patients without adequate asthma control on medium to high-dose inhaled steroids associated with long acting beta adrenergic drugs. The hypothesis is that there is no clinical efficacy difference between the two forms of drug administration.