105 Clinical Trials for Various Conditions
The primary objective is to determine whether continuous sensing, control and mitigation of home indoor air quality influences the frequency of asthma related symptoms, as measured by Serum IgE, Spirometry with exhaled Nitric Oxide, missed school and workdays, need for pharmacologic intervention (albuterol, oral steroids), frequency of sick visits to pulmonologist or primary care provider (PCP), urgent care / emergency department visits, and hospitalizations
ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.
This study is a two strata, dose escalation Phase I clinical trial designed to assess the safety and determine the maximal tolerated dose (MTD) of allogenic cord tissue derived MSCs (cMSCs, stratum 1) and allogeneic, interferon-γ primed bone marrow MSCs (γMSCs, stratum 2). Each stratum is designed to independently accrue 3 children at a dose level 1 of 2x106 cells/kg and 6 children at dose level 2 of 10x106 cells/kg, resulting in 9 children in each stratum. The primary objectives are to determine the safety and toxicity of allogeneic cord tissue derived MSCs and allogeneic interferon-γ primed bone marrow derived MSCs.
This study will evaluate the efficacy, safety of two dose levels of CBP-201 in patients with moderate to severe persistent asthma with Type 2 inflammation.
Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: * To evaluate the effect of dupilumab on additional participant reported sleep outcomes * To evaluate the effect of dupilumab on objective sleep assessment * To evaluate the effect of dupilumab on asthma symptoms * To evaluate the effect of dupilumab on lung function * To evaluate the safety of dupilumab
The purpose of this study is to assess the safety and tolerability of a 6-week Inspiratory Muscle Training and cardiovascular exercise training program in children and adolescents with asthma. To also determine the efficacy of inspiratory muscle training and exercise in increasing respiratory muscle strength and endurance, and to explore relationships between fitness interventions (inspiratory muscle training and exercise), exercise tolerance, airway closure and dyspnea scores.
This is a behavioral randomized controlled trial of adults with uncontrolled persistent asthma that tests if the Propeller Health sensor, mobile application, and dashboard can improve adherence to ICS.
The main hypothesis of this study is to see if children and adolescents with poorly controlled asthma will find the Propeller electronic monitoring device is feasible and acceptable, and will result in improved medication adherence and asthma control. Preliminary studies indicate that Propeller can improve medication adherence rates in children with asthma and reduce the number of days of reliever medication used. It also has been shown to reduce missed days of school and hospitalizations due to asthma exacerbations. The Propeller device is a sensor that fits over inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication. It also records use of the controller and rescue inhalers, allowing for parents, physicians, and patients to get a fuller and more accurate picture of their adherence to treatment and severity of disease. With improved adherence, asthma control should improve, resulting in a decreased costs and use of services.
The goal of this study is to evaluate a pilot of clinic-based intervention of asthma education. After a scheduled outpatient encounter for well-child care or asthma care has concluded, a pediatric nurse will teach participants (children and their caregivers) about asthma, provide clearly written information about how to manage asthma, and discuss how to manage asthma at home with cooperation between caregivers and children. Families will also receive current asthma prescriptions in clinic, and colored labels will be attached to medications in order to match the color scheme of asthma action plans (green labels for controller medications, red labels for rescue medications). Families will be followed for 3 months after the first clinic visit, including a follow-up visit in clinic 1 month later and a follow-up telephone call 3 months after starting. The nurse will reinforce key educational points and review medication use at the follow-up clinic visit. Families will also be invited to complete an additional in-depth interview following the 1 month clinic follow-up. The investigator hypothesizes that knowledge, self-efficacy, and reported adherence with asthma medications will increase for both caregivers and children/adolescents following the intervention and labeling of delivered medications. In addition, the investigator hypothesizes that children/adolescents will have more symptom free days and improved control following the intervention.
This study is designed to note whether a larger safety study using quadrivalent live attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients in this study will receive the FLUARIX® influenza vaccine, while the other half will receive a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as a surrogate for LAIV4.
This is a pivotal, 12-month, randomized, sham controlled, parallel group, multicenter, double blind study with an allocation ratio of 1:1. The study population is children between the ages 6 to 17 years, with mild to moderate persistent asthma. The purpose of the study is to determine whether the CREON2000A, an environmental control device, will decrease asthma severity, as measured by the Composite Asthma Severity Index (CASI), in children with mild to moderate persistent allergic asthma over a twelve month period.
The New York City Department of Health and Mental Hygiene and Montefiore Medical Center, with the Fund for Public Health of New York (FPHNY), DOHMH's fiscal agent, are partnering on a study to evaluate the feasibility, health outcomes and return-on-investment of a single, integrated pest management (IPM) intervention for Bronx, Harlem, and Northern Manhattan children aged 5 to 12 with persistent asthma who are living in homes with pests. By demonstrating cost effectiveness, this study could provide the basis for health insurance coverage of an IPM visit embedded in clinical treatment plans for high-risk asthma patients living with pests. Asthma is the most common childhood disease in New York City, and both prevalence and hospitalization rates are highest in high-poverty neighborhoods. The greatest individual and community-level factor associated with asthma disparities is varying exposure to triggers in the home, most notably cockroaches and mice. Asthma health care costs are significant, and prevention efforts to reduce triggers could result in improved outcomes and significant cost savings. Unlike traditional pest control, which relies on pesticides, IPM eliminates pests and prevents re-infestation by addressing housing conditions conducive to pests and with safe, targeted use of pesticides. This project targets low-income children with the potential to significantly improve their health and well-being. A total of 400 families - 400+ children which includes screened and recruited siblings - will be recruited on to the study. The study is designed to evaluate an inexpensive and scalable environmental intervention for asthma that can be replicated in other New York City neighborhoods and incorporated into any urban healthcare setting in New York State and nationwide.
Purpose: To determine the measurement properties of the asthma control test (ACT) in a prospective clinical study in an African American adolescent population.
To determine the measurement profiles of the asthma control test (ACT) in an adolescent population with persistent asthma.
The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 6 weeks (AUEC\[0-6wk\]).
The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).
Each patient will participate in the study for approximately 7 weeks. Participation will include a screening period of up to 21 days and 4 treatment periods; each consisting of a 3-day/2-night inpatient period.
A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma
Primary Objective: To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life. * To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.
The purpose of this trial is to confirm the safety and clinical benefit of benralizumab administration in asthma patients with mild to moderate persistent asthma in order to gain an understanding of the benefit/risk of benralizumab across the spectrum of asthma disease.
This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate \[FP\]/salmeterol 250/50 microgram \[mcg\]twice daily \[BD\]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA. SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.
The purpose of this study is to investigate the cytokine levels in nasal lavage and gene expression in nasal scraping following a single nasal dose of JNJ-43260295 in healthy participants, and in atopic mild to mild-persistent asthmatic (breathing disorder in which there is wheezing and difficulty in breathing) participants with and without nasal allergen challenge prior to dosing.
The primary objective of the study is to evaluate the long-term safety of fluticasone propionate (Fp) inhalation powder in 2 strengths and fluticasone propionate/salmeterol inhalation (FS) powder in 2 strengths when administered with the Teva multidose dry powder inhaler (MDPI) device over 26 weeks in patients with persistent asthma.
The primary objective of this study was to evaluate the efficacy of fluticasone propionate (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS) MDPI when administered over 12 weeks in patients 12 years of age and older with persistent asthma.
The primary objective of this study was to evaluate the efficacy of fluticasone propionate multidose dry powder inhaler (Fp MDPI) and fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (FS MDPI) when administered over 12 weeks in patients 12 years of age and older with persistent asthma. Study drug and placebo was supplied in Teva multidose dry powder inhaler (MDPI) devices and provided for participants to use at home. Participants performed spirometry at every visit. Each participant was given a diary at each visit for use until the next visit. Rescue medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by the investigational center personnel.
Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.
This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study
This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo. Patients took 1 inhalation (with assistance from parents/guardians/caregivers, as needed) from each of 2 devices (BAI device followed by MDI device in that order) twice daily as per the double-dummy study design: 1 BAI treatment or placebo device and 1 MDI treatment or placebo device for a total of 2 inhalations each time.
This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.
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.