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Asthma clinical trials

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NCT ID: NCT01192360 Completed - Asthma Clinical Trials

Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease

Start date: September 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine if quantitative Dynamic contrast-enhanced magnetic resonance (DCE MR) perfusion imaging accurately quantifies right and left pulmonary artery blood flow as compared with phase contrast flow velocity mapping (PC), the current gold standard of flow volume measurements.

NCT ID: NCT01192178 Completed - Asthma Clinical Trials

Fall Epidemic Viral Pediatric Study

Start date: August 2010
Phase: Phase 4
Study type: Interventional

Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316 subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment starting in April 2010. Eligible subjects will be invited to return for randomization into the study in August 2010. This exploratory study is being conducted to assess whether treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of exacerbation and the asthma impairment associated with viral respiratory tract infections during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.

NCT ID: NCT01191424 Completed - Asthma Clinical Trials

A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.

ADONE
Start date: October 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.

NCT ID: NCT01190826 Completed - Asthma Clinical Trials

Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma

Start date: August 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and clinical activity of ASM-024 in stable moderate asthma.

NCT ID: NCT01189396 Completed - Asthma Clinical Trials

Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006

Start date: July 2010
Phase: Phase 2
Study type: Interventional

The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.

NCT ID: NCT01188577 Completed - Asthma Clinical Trials

Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics

Start date: August 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.

NCT ID: NCT01187147 Completed - Asthma Clinical Trials

Effects of Green Tea Extract (GTE) on Systemic Oxidative and Antioxidative Status in Chinese Patients With Stable Asthma

Start date: January 2008
Phase: N/A
Study type: Interventional

Asthma is a disease characterized by chronic inflammation in the airways. Recent research has demonstrated that one of the reasons for the chronic inflammatory state is an imbalance between oxidative stress and antioxidative defenses in patients with asthma. Green tea is a common beverage consumed by Chinese patients from all walks of life. Green tea contains chemical components that are thought to have immunomodulatory actions in chronic inflammation. The investigators propose to recruit 35 patients with stable asthma. Recruited subject will be given oral tablets containing Green tea extract (GTE) to be taken daily for three months. Clinical follow up and assessment will be done at baseline, on completion of GTE intake at three months, and at three months after GTE intake has been stopped. A questionnaire on their health status and the frequency of symptoms and use of bronchodilators and inhaled steroids will be completed, spirometry will be done and a venous blood sample will be taken during recruitment and during each reassessment at 3 and 6 months. Measurement of oxidants/antioxidants (GSH, GSSG, SOD, CAT and GPx) will be carried out on the blood samples. Oxidants/antioxidants will be compared and correlated with lung function results. This study would provide us with pilot data as to whether GTE, a strong antioxidant with immunomodulatory actions, has any effect on reducing the oxidative stress and improving the antioxidant status in patients with asthma and whether these changes are accompanied improvement in clinical status. Hypothesis Green tea extract (GTE) reduces oxidative stress and improves antioxidant defenses in Chinese patients with asthma

NCT ID: NCT01185275 Completed - Asthma Clinical Trials

A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)

BTR
Start date: August 2010
Phase:
Study type: Observational

Clinical response, as defined by improvement in asthma quality of life, to bronchial thermoplasty in patients with severe refractory asthma can be predicted through the use of clinical, physiologic, biologic and imaging markers.

NCT ID: NCT01181895 Completed - Asthma Clinical Trials

Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma

Start date: September 1, 2010
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.

NCT ID: NCT01181063 Completed - Asthma Clinical Trials

Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers

Reco-Pilot
Start date: August 2010
Phase: Phase 1
Study type: Interventional

Due to the complexity of orally inhaled products (combination of a formulation and a device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo correlation(IVIVC) for inhaled dosage forms is not generally known. The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH product variants under development and compare pulmonary deposition (administration with charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.