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Asthma clinical trials

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NCT ID: NCT01544634 Completed - Asthma Clinical Trials

Beta Blocker Therapy in Mild to Moderate Asthmatics

ANDA1
Start date: April 4, 2012
Phase: Phase 2
Study type: Interventional

Current asthma medicines include inhalers. A common type of inhaler is called a 'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the airway causing it to widen. Although these drugs are useful short term, long term use can make asthma worse in some people. 'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in patients with asthma. Beta-blockers cause problems in asthmatics in the short term, including severe asthma attacks. The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer' medication. These work by dampening down the inflammation in the lungs that occurs in asthma. New research has suggested that longer term use of beta-blockers can also reduce airway inflammation which may improve asthma control. This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. At the moment the investigators are studying to see if there is a benefit of beta-blocker use for asthma over and above asthmatics own usual doses of inhaled steroids. In this study, the investigators will be trying to find out if adding a beta blocker to a smaller dose of steroid inhaler has the same effect on asthma control as just using a higher dose of steroid inhaler by itself.

NCT ID: NCT01543516 Completed - Clinical trials for Bronchial Asthma With eNO-levels Greater Than 30 ppB

Cell Distribution in Induced Sputum in Patients With Asthma

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

The aim of this case-control study is the comparison of the cell distribution in induced sputum in young adults with asthma and in healthy controls. The study consists of two visits. At both visits subjects are asked to perform a lung function test (body plethysmography) and levels of exhaled nitric oxide (eNO) are measured. At the first visit a blood sample is drawn to determine the inflammatory and allergic status of the subjects and the sputum is induced by an ultrasonic nebulizer. At the second visit another sputum sample is induced by a nozzle nebulizer. The cell distribution will be evaluated in both sputum samples.

NCT ID: NCT01540708 Completed - Asthma Clinical Trials

A Single Centre Study in Healthy Volunteers to Optimise the Rotacap Formulation and ROTAHALER Device for Delivery of Fluticasone Propionate/Salmeterol

Start date: January 16, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to optimise the device and/or formulation of the Fluticasone propionate (FP)/salmeterol (SALM) unit dose powder inhaler (Rotahaler) to achieve drug delivery characteristics comparable to the Fluticasone propionate /salmeterol DISKUS inhaler. The indication is asthma and chronic obstructive pulmonary disease. The study is an open-label, randomised, cross-over, single centre study in healthy volunteers and will be conducted in a maximum of 3 parts, A, B and C. The design is adaptive and pharmacokinetic (PK) data analysis follows each part to enable a decision on whether progression to the subsequent parts is required. Part A of the study will test an alternative version of the Rotahaler with a low airflow resistance. The study will then test one or more of the following options depending on the outcome of part A. If progressed, part B will test modified Rotacap formulations including: (1) modified blend formulation, (2) reduced capsule fill weights, (3) different capsule types. Part B will also test other versions of the Rotahaler with intermediate airflow resistance. Part C will test the lower strength FP/salmeterol (100/50 mcg or lower) and/or a new unit dose DPI device (BUDI). A total of 36 subjects will be enrolled in each part to ensure 32 complete. In each cross-over arm, subjects will be administered 7 doses (3.5 days bid) with PK sampling following administration of the 7th dose. A three-day minimum wash-out period will separate each cross-over arm.

NCT ID: NCT01537133 Completed - Asthma Clinical Trials

Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment

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

There are new, very sensitive methods for detecting bacteria. These methods show that hundreds of millions of microbes (organisms that can only be seen with microscopes), especially bacteria, live in healthy people. The collection of different microbes found in a site is called a "microbiome." The investigators know that microbiomes of the skin, sinuses, mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome - which bacteria are found in a site - may be necessary for good health. For example, the microbiome of the mouth is different in people with inflammation of the gums (periodontitis), and the microbiome of the bowel is different in people with inflammation of the intestinal tract (inflammatory bowel disease). The purpose of this research study is to find out if the microbiome in the lungs is different in healthy people without asthma compared to people with asthma. This study will also find out if the microbiome of the lungs changes when people with asthma take a daily "controller" medication called an inhaled corticosteroid.

NCT ID: NCT01536457 Completed - Asthma Clinical Trials

Reflux Disease Therapy in the Management of Childhood Asthma-data Entry and Analysis Only

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

There have been a number of studies which attribute causality between reflux disease and asthma. In addition, clinicians typically treat chronic asthmatics with high dose acid suppressing medications (e.g. lansoprazole). However, clinical trials only recently have shed some light on this dilemma, with recent studies suggesting that the association is not as clear. This "retrospective" analysis of a prospective study which treated mod-severe asthmatics with lansoprazole or placebo will enter the collected raw data into a database, then perform statistical analyses to determine if children with asthma treated with acid suppression improved their asthma compared to those receiving placebo.

NCT ID: NCT01536041 Completed - Asthma Clinical Trials

A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are: i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced expiratory volume in 1 second (FEV1) after exercise challenge ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg of ONO-6950 in asthmatic patients. The secondary objectives of this study are: i. to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise challenge ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg) single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.

NCT ID: NCT01532817 Completed - Asthma Clinical Trials

Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore Device

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

The purpose of this pilot study is to collect preliminary clinical data related to the safety and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™ device for the relief of acute bronchoconstriction due to asthma. Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic settings capable of treating any potential complications of bronchoconstriction, an acute exacerbation of asthma, and any emergencies associated with use of the investigational device.

NCT ID: NCT01529697 Completed - Asthma Clinical Trials

Prospective Study of the Feedback From an Adherence Monitor on Asthma Control

INCA
Start date: February 2012
Phase: N/A
Study type: Interventional

Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified. In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.

NCT ID: NCT01529437 Completed - Asthma Clinical Trials

Sublingual Immunotherapy Studies for Grass and Dust Mite Allergies

SLIT
Start date: January 2005
Phase: Phase 1
Study type: Interventional

This is a study for children and adults who are interested in a new therapy for their allergies to dust mite and timothy grass. The new therapy is called sublingual immunotherapy and the investigators are testing if it is safe and well tolerated.

NCT ID: NCT01526707 Completed - Asthma Clinical Trials

The Use of FKBP51 in the Identification of Non-adherence to Inhaled Corticosteroids in Difficult Asthma

Start date: June 2011
Phase: N/A
Study type: Interventional

Approximately 5−10% of people with asthma do not respond to to standard therapy and are referred to as having difficult asthma. Evidence shows that this poor response is not always related to asthma severity and non−adherence to treatment is recognized as a common underlying problem, in 35% of these patients. Recognising non−adherence in the clinic is problematic as there is no straightforward objective test to identify it. Previous studies have demonstrated up-regulation of FKBP51 gene expression following treatment with steroids, making it a potential biomarker of steroid exposure. It is therefore also a potential biomarker of non-adherence to inhaled corticosteroid therapy. The investigators plan to assess the feasibility of distinguishing non-adherent subjects who are by omission steroid naïve from adherent subjects, steroid exposed subjects using FKBP51 gene expression in sputum and throat swabs. To do this the investigators will obtain throat swab and sputum samples from healthy volunteers, steroid naïve asthmatics and adherent asthmatics on high dose ICS to assess if FKBP51 gene expression is comparable in each group. The investigators will then compare the FKBP51 gene expression response to directly observed inhaled steroid therapy in steroid naïve, non-adherent and adherent asthmatics. This will identify if the response in gene expression distinguishes steroid exposed (adherent) from steroid naïve (non-adherent) patients. Identifying non-adherence will benefit patients by enabling appropriate tailored management for non-adherence to enhance treatment effectiveness. It will also identify patients with therapy resistant asthma who have an unmet need and may benefit from expensive novel therapies such as Omalizumab.