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Asthma clinical trials

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NCT ID: NCT01999907 Completed - Asthma Clinical Trials

Vitamin D to Reduce Colds and Asthma Attacks in Young Children

DIVA-pilot
Start date: November 2013
Phase: Phase 2
Study type: Interventional

Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.

NCT ID: NCT01997463 Completed - Childhood Asthma Clinical Trials

Supervised Asthma Medication in Schools (SAMS)

SAMS
Start date: August 2014
Phase: Phase 4
Study type: Interventional

The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.

NCT ID: NCT01997047 Completed - Asthma Clinical Trials

Diagnosing Pneumonia Under Low-resource Conditions

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

Pneumonia is the commonest cause of death in children worldwide, killing 1.5 million children under the age of 5 years, every year. This is more than the number of children dying from AIDS, malaria and tuberculosis combined. The current diagnostic and management protocols for managing serious respiratory diseases in children are 30 years old and are greatly in need of updating. The successful establishment of useful clinical management criteria for children with respiratory diseases will have benefits for children in low resource regions around the world. The goals of the study are: - To determine if children with respiratory distress can be reliably diagnosed under low-resource conditions. - To identify the clinical tests that best differentiate pneumonia from wheezy diseases. These will be used to establish updated diagnostic criteria for common pediatric lung diseases that broaden the current pneumonia algorithm by adding another for wheezy illnesses. - The ultimate objective is to improve the management and outcome of acute respiratory conditions in children. - Investigators also wish to test the efficacy of a locally developed cell phone oximeter probe in a low resource setting.

NCT ID: NCT01993329 Completed - Asthma Clinical Trials

A Study to Evaluate the Effect of Gefapixant (AF-219/MK-7264) on Methacholine Hyper-reactivity in Participants With Asthma (MK-7264-009)

Start date: December 16, 2013
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, single centre study in participants with asthma undergoing inhalation of methacholine and adenosine triphosphate (ATP) to assess the provocative concentration (PC20) response of two dose levels of gefapixant (AF-219) compared with placebo.

NCT ID: NCT01987492 Completed - Asthma Clinical Trials

A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

Start date: February 28, 2014
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.

NCT ID: NCT01985789 Completed - Asthma Clinical Trials

Anti-histamines and Methacholine Challenges.

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

The asthmatic airway is identified and studied using inhaled agents such as histamine and methacholine. The use of antihistamines prior to the test will inhibit the test result if histamine is used to cause airway constriction. If using methacholine, this may also be true depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used. This study will look at the effect of old and new antihistamines on inhaled methacholine challenge response in individuals with mild asthma.

NCT ID: NCT01984281 Completed - Asthma Clinical Trials

Effects of a Pedometer-based Unsupervised Exercise Program Upon Lifestyle Physical Activity of Asthmatic Adults

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a pedometer-based unsupervised exercise program is more effective than a general exercise recommendation to increase lifestyle physical activity in adult patients with asthma.

NCT ID: NCT01984086 Completed - Asthma Clinical Trials

Study to Evaluate the Pharmacokinetic Profile of Salbutamol Delivered by Unit Dose Dry Powder Inhaler (UD-DPI) Compared to the Diskus and Metered Dose Inhaler (MDI) in Healthy Volunteers.

Start date: October 21, 2013
Phase: Phase 1
Study type: Interventional

This is an open-label, two part, six period- cross over, randomised, single dose, single centre study in healthy subjects. This is the first clinical study for the UD-DPI. This study is divided into two parts. Part A will ascertain whether the pharmacokinetic (PK) of salbutamol delivered via the UD-DPI is comparable to the salbutamol delivered via the Diskus or MDI. For this reason four treatment doses consisting of three dose strength and two percentage blends will be assessed in Part A delivered via UD-DPI. Part A will also provide preliminary PK variability estimates to allow for better sample size/precision calculations for Part B. Part B will explore whether the UD-DPI has a pharmacokinetic exposure profile that is comparable to either Diskus or MDI in the presence of the charcoal block.

NCT ID: NCT01982162 Completed - Asthma Clinical Trials

Longitudinal Assessment of Children With Severe Asthma and Severe Pre-school Wheeze

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

Cross-sectional study to characterize cohorts of children with asthma and healthy controls in terms of clinical features, physiological measurements and non-invasive measurement of biomarkers and develop phenotype handprints for children with severe asthma

NCT ID: NCT01981564 Completed - Asthma Clinical Trials

Asthma Express: Bridging the Emergency to Primary Care in Underserved Children

Start date: April 15, 2013
Phase: N/A
Study type: Interventional

Asthma is the number one cause of pediatric emergency department (ED) visits in young minority children and is responsible for high healthcare costs. The ED is often the point of contact for many inner city children and many families view the ED as the child's primary source of asthma care. This study plans to test a new model of asthma care, Asthma Express (AEx), that includes a follow-up asthma visit in the ED for an asthma "check-up" , asthma education, a prescription for preventive asthma medications, an appointment for the child to see their pediatric provider and a home visit to assist families with environmental control methods to prevent asthma symptoms.