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Asthma clinical trials

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NCT ID: NCT03795350 Terminated - Asthma Clinical Trials

Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients

STORM
Start date: January 14, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the lung deposition and distribution pattern of TRIMBOW using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled TRIMBOW administered via pMDI in healthy volunteers, asthmatic and COPD patients

NCT ID: NCT03794999 Terminated - Asthma Clinical Trials

Benralizumab Pregnancy Exposure Study

Start date: March 20, 2019
Phase:
Study type: Observational [Patient Registry]

This is a prospective, observational, exposure cohort study of pregnancy and infant outcomes in women with asthma exposed to benralizumab anytime during pregnancy, or within 8 weeks prior to the first day of the last menstrual period (LMP) The objective of the study is to monitor planned or unplanned pregnancies to evaluate potential teratogenic effect (birth defect) when exposed to benralizumab compared to two unexposed comparator groups. The primary outcome is major structural birth defects (abnormalities in development of structures of the body) and the secondary outcomes are preterm delivery (premature baby), small for gestational age infants (small for weight, length, and/or head circumference), spontaneous abortion (miscarriage), stillbirth (baby born without signs of life), elective termination (voluntary abortion) and small for age postnatal growth to one year of age (small for weight, length and/or head circumference). The birth prevalence or incidence of outcomes in women exposed to benralizumab, and their infants, will be compared to those observed in two unexposed comparator groups: a disease-matched comparison group of women who have not used benralizumab during pregnancy or within 8 weeks of their last menstrual period (LMP), but who have used other anti-asthmatic medications (treated disease comparison group), and a comparison group of healthy women who do not have a diagnosis of asthma, have not had exposure to a known human teratogen (substance that causes birth defect), and have not taken benralizumab in pregnancy (healthy comparison group).

NCT ID: NCT03794856 Recruiting - Asthma Clinical Trials

The Dallas Asthma Brain and Cognition (ABC) Study

Start date: February 21, 2019
Phase:
Study type: Observational

Asthma is a chronic inflammatory airway disease that leads to episodic symptom exacerbations, which exerts a substantial burden on quality of life and can influence other health domains if not adequately controlled. Asthma prevalence rates have increased in the past decade, affecting 8.4% (25.7 million people) of the United States population. The economic costs of asthma have been estimated annually with $56 billion in the US alone. Despite progress in pharmacological treatment, overall asthma control remains unsatisfactory and treatment non-adherence is extremely high. Asthma is particularly under diagnosed and understudied in aging adults. This problem will increase in coming decades given demographic trends and will disproportionally contribute to the societal and personal economic costs associated with asthma treatment and management. In the proposed 4-year project we will evaluate, in a two-session assessment recruiting a total of 126 asthma patients and 66 healthy controls aged 40-69 years, the extent to which asthma and aging are associated with changes in cognition and brain chemistry, structure, and function.

NCT ID: NCT03791658 Completed - Asthma Clinical Trials

Assessment of Adherence to Controller Inhalation Medication in Asthma- and COPD Patients.

Start date: January 2, 2019
Phase: N/A
Study type: Interventional

The main aim of the study is to evaluate the adherence to controller inhalation medication in asthma and Chronic Obstructive Pulmonary Disease (COPD) in Universitair Ziekenhuis Brussel. Adherence will be assessed using the 12-question Test for the Adherence to Inhalers (TAI) yielding a score indicating level of adherence (high, intermediate or poor). The TAI also provides some indication about the possible mechanisms of non-adherence (sporadic, deliberate or unconscious). The aim of the study is also to compare the adherence between the 2 study subgroups (asthma and COPD patients). Several other factors which could influence the compliance of the patients will also be evaluated: age, sex, pack years, FEV1 (Forced Expiratory Volume 1), exacerbation history, symptom control, type of inhaler and number of inhalers. By identifying different patient and treatment characteristics that lead to non-adherence, future education efforts could be better targeted to these patients presenting the most important unmet need in terms of adherence.

NCT ID: NCT03788395 Completed - Asthma Clinical Trials

The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma

Start date: January 10, 2019
Phase: Phase 4
Study type: Interventional

The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age. In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application. The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.

NCT ID: NCT03788057 Recruiting - Asthma Chronic Clinical Trials

Inflammatory Indices in Predicting the Failure of Inhaled Corticosteroids Reduction in Young Participants With Asthma

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

A prospective, observational, interventional, single-blind study (blinded for a clinician in the field of inflammatory parameters). The aim of the study is evaluation of the usefulness of induced sputum eosinophilia and other inflammatory indices [exhaled nitric oxide (NO), exhaled breath temperature, bronchial hyperresponsiveness] in predicting the failure of treatment reduction with inhaled corticosteroids (ICS) in stable asthma in children and adolescents. In participants with a stable course of the asthma (confirmed in the run -in period), every 3 months the dose of ICS is halved (according to GINA guidelines) until the control is lost or the lowest daily ICS dose is reached (200 mcg, calculated as budesonide equivalent). Throughout the treatment reduction period, the participants run an observation card (clinical symptoms) and peak expiratory flow rate (PEFR) measurements. Clinical evaluation is performed every month, with spirometry, exhaled NO and exhaled breath temperature measurements. Before the reduction and then one month after the change of treatment, the hyperresponsiveness measurement is carried out with the sputum induction (combined method using hypertonic saline), and 2 months after the change of treatment with the exercise challenge test. In the case of loss of asthma control, beta-mimetic will be administered (temporarily) and return to dose of ICS before reduction or further increase of treatment is planned. In severe asthma exacerbations, oral steroids will be considered. The study is observational: treatment is modified according to GINA guidelines based on clinical data as part of routine medical care. Only difference compared do standard care is supplementary inflammation evaluation (exhaled NO, sputum eosinophilia, bronchial hyperreactivity).

NCT ID: NCT03784781 Withdrawn - Severe Asthma Clinical Trials

Type 2 Innate Lymphoid Cells in Severe Pediatric Asthma

CLASSE
Start date: June 9, 2016
Phase:
Study type: Observational

The main objectives of this study are to show that the number of type 2 innate lymphoid cells (ILC2) of the bronchial mucosa and in bronchoalveolar lavages (BAL) are higher in asthmatic children than in non-asthmatics, that the number of ILC2 of the bronchial mucosa and in BAL correlate with the number of bronchial and BAL eosinophils, and to determine whether there is a correlation between plasma and bronchial and BAL ILC2.

NCT ID: NCT03782532 Completed - Asthma Clinical Trials

Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

Start date: January 25, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab in patients with persistent asthma Secondary Objectives: - To evaluate the safety and tolerability of dupilumab - To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life - To evaluate dupilumab systemic exposure and immunogenicity

NCT ID: NCT03780387 Terminated - Asthma Atopic Clinical Trials

Identification of Allergic Asthmatics Reactive to Felis Catus (Cat Hair) Allergen Inhalation

Start date: April 16, 2019
Phase: Early Phase 1
Study type: Interventional

This study is designed to identify Felis Catus, or cat hair, sensitive asthmatics who demonstrate a late phase asthmatic response after cat hair inhalation. These subjects may be invited to participate in a planned future study investigating novel asthma treatments.

NCT ID: NCT03779152 Completed - Asthma Clinical Trials

Regulation of CCL18 by Corticosteroids in Severe Asthma

CCL18
Start date: February 2009
Phase:
Study type: Observational

The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.