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Asthma clinical trials

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NCT ID: NCT01961258 Not yet recruiting - Severe Asthma Clinical Trials

"SEVERE ASTHMA" in the COMMUNITY

Start date: June 2015
Phase: N/A
Study type: Observational [Patient Registry]

SEVERE ASTHMA IN THE COMMUNITY- BACKGROUND Severe asthma is a common problem. In the world approximately 300 million people have asthma but it is estimated that only 5% of these patients have severe asthma. Although "severe asthma" comprises a small fraction of the entire asthmatic population its share in the total economic burden of asthma is 80 percent. In Israel the prevalence of asthma among adult patients is about 5-6% but the prevalence of severe asthma is unknown. The definition of severe asthma has been changed during the years. Most recently in 2009 the WHO agreed on a unified definition of "severe asthma" that would fit countries of different socioeconomic development [1]. Severe asthma includes now 3 different groups: group one "untreated severe asthma", group two "difficult to treat severe asthma" and group three "treatment-resistant severe asthma". As all asthmatic patients in Israel have easy access to medical care, the current study will deal with the last two groups ("difficult to treat asthma" and "treatment resistant asthma"). AIMS Primary endpoints: 1. To identify the prevalence of severe asthma in the community according to the WHO definition of group two & three. 2. To assess whether anti-IgE therapy (Omalizumab), was considered in these groups of severe asthma. Secondary endpoints: 1. To assess factors involved in "difficult to treat asthma" according to the WHO definition. Factors as patient compliance, presence of co-morbidities, symptoms of untreated potential asthma triggers including GE reflux, post nasal drip/atopic rhino-sinusitis, and intervening medications including NSAID and beta-blockers. 2. To asses the level of asthma control, level of patient follow-up care including asthma specialist visits, periodic PFT's and asthma education. 3. To assess the fraction of patients with severe asthma that is eligible to anti-IgE therapy according to the indications of the Israeli Ministry of Health (proven asthma, uncontrolled by high dose of combined ICS+LABA inhaler therapy + at least 2 courses of systemic corticosteroids in the last year + proven atopy to at least one perennial aeroallergen + IgE level of 30-1,500 IU/ml) DESIGN A prospective non-blinded non-randomized observation study among the population insured by Clalit Medical Services (CMS) in the Sharon- Shomron Medical District in Israel.

NCT ID: NCT01961154 Completed - Asthma Clinical Trials

Stepping Down of Asthma Medication in Controlled Asthma

Start date: October 2012
Phase: N/A
Study type: Interventional

Background: The most common asthma drugs, namely inhaled glucocorticoids (ICS) and long-acting beta-2 sympathomimetic drugs (LABA) carry a risk of adverse effects, some of which being potentially severe. Therefore, current guidelines for asthma management recommend that, after a period of symptom control, a reduction of the dose and cessation of the ICSs and LABAs should be attempted. However, reduction in asthma medications sometimes leads to an exacerbation of asthma. Therefore both physicians and asthmatics are often reluctant to reduce or stop asthma medications and asthma over-medication often occurs. A test that could identify those asthmatics who probably would tolerate asthma medication reduction would be useful. Objectives: 1. To investigate whether airway responsiveness to hypertonic saline can predict the outcome of asthma treatment reduction in subjects with controlled asthma. 2. To get an estimate about how large a proportion of Finnish asthmatic patients use their medications with unnecessarily high doses or would even manage well without any asthma medications. Study hypothesis: 1. Airway responsiveness to hypertonic saline can predict the outcome of asthma treatment reduction 2. Most of the Finnish asthmatic patients use their medications with unnecessarily high doses Methods: This is a prospective study in which the physician responsible for the subject management and medications is blinded from the saline challenge results and the nurse performing the saline challenges is blinded from medications 70 asthmatic patients with both inhaled ICS and LABA will be recruited. Asthma must be well controlled (Juniper's Asthma Control Questionnaire score equal or less than 0.75 ). The asthma medications will be reduced in three steps, in six weeks' intervals, up to total cessation of asthma drugs or up to asthma exacerbation. The criteria for asthma exacerbation are strictly defined. First step: LABA will be discontinued. The ICS is continued. Second step: medium to high daily ICS dose is reduced to low daily dose. Third step: The low ICS dose will be stopped. Before each reduction, saline challenge will be performed. Asthma diary is kept throughout the study and the subjects will be provided a direct telephone number to a respiratory physician during all hours of day.

NCT ID: NCT01959412 Completed - Asthma Clinical Trials

Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma

QAB149
Start date: November 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.

NCT ID: NCT01955512 Completed - Asthma Clinical Trials

Effect of Clopidogrel on Allergen Challenge in Asthma

Start date: May 2013
Phase: Phase 2
Study type: Interventional

In asthma, breathing in an allergen, such as house dust mite induces inflammation in the airways. This process appears to involve an interaction between two different sorts of blood cells, platelets and white blood cells via a receptor called the P2Y12 receptor. The purpose of this study is to determine whether the drug clopidogrel which blocks the P2Y12 receptor on platelets, reduces inflammation following breathing in house dust mite in people with mild asthma.

NCT ID: NCT01951898 Recruiting - Asthma Clinical Trials

Effects of Montelukast on Airway Regulatory T Cells in Asthma

Start date: June 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Montelukast is one of anti-inflammatory agents and a good controller for the patients with asthma. The hypothesis of the study is that the Montelukast will have airway anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.

NCT ID: NCT01951378 Terminated - Asthma Clinical Trials

Comparison of Nebulizers in ED in Pediatric Asthma Patients

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The primary objective will be, in an open-label randomized trial, a comparison of emergency department (ED) length of stay (LOS) between children experiencing acute asthma treated with two different nebulizers. Secondary outcomes will include admission rates, hospital LOS, need for additional therapies, transfers to a higher level of care, side-effects, and unscheduled return visits

NCT ID: NCT01951222 Completed - Asthma Clinical Trials

Bronchodilator Properties and Safety in Asthma

Start date: September 2013
Phase: Phase 2
Study type: Interventional

Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA. V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Secondary properties of V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. The objective of the study is to assess the bronchodilator properties of V0162 during 8 days in adult patients with asthma usually treated with ICS and LABA. The study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.

NCT ID: NCT01948401 Completed - Asthma Clinical Trials

A Study to Measure Serum Periostin, Asthma-Related Biomarkers and Response to Prednisolone in Adult and Adolescent Patients With Severe Oral Corticosteroid-Dependent Asthma

Start date: July 2013
Phase: Phase 2
Study type: Interventional

This interventional, open study will evaluate clinical data in relation to biomarkers in patients 12 to 75 years of age with severe oral corticosteroid (OCS) - dependent asthma. Patients with uncontrolled asthma will be offered an additional escalation of OCS at a dose of 0.5 mg/kg for 7 days. Patients enrolled in this study would be eligible to be enrolled in a future placebo-controlled intervention study designed to measure the steroid-sparing effect of lebrikizumab.

NCT ID: NCT01947946 Terminated - Asthma Clinical Trials

Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

Start date: November 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.

NCT ID: NCT01943942 Completed - Asthma Clinical Trials

Bioequivalence Study of Montelukast 10 mg Tablets

Start date: May 16, 2010
Phase: Phase 1
Study type: Interventional

The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent. Test product was Montelukast (10 mg tablets; GlaxoSmithKline) and reference product Singulair (10 mg tablets; Merck Sharp & Dohme). The single dosage was one tablet. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 32 healthy volunteers, both genders, adults between 18-50 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.