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Lung Deposition of Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide Administered Via pMDI in Healthy, Asthmatic and COPD Patients

2016-11-30 15:45:44 | BioPortfolio

Summary

The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled CHF 5993 Administered via pMDI in healthy volunteers, asthmatic and COPD patients.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Obstructive Pulmonary Disease

Intervention

Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium

Status

Not yet recruiting

Source

Chiesi Farmaceutici S.p.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-30T15:45:44-0500

Clinical Trials [2003 Associated Clinical Trials listed on BioPortfolio]

Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Diseas

The purpose of the study is to demonstrate the triple combination of beclometasone dipropionate + formoterol fumarate + glycopyrronium bromide is effective in term of quality of life in CO...

BDP/FF (Beclomethasone Dipropionate) Versus Formoterol Fumarate (FF) in Patients With Severe Chronic Obstructive Pulmonary Disease

a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

Efficacy of Fixed Combination of Beclomethasone + Formoterol + Glycopyrrolate Versus Foster® in Chronic Obstructive Pulmonary Diseases

Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of Beclometasone+Formoterol+Glycopyrrolate a...

Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb).

To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized ...

TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA

The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrro...

PubMed Articles [9548 Associated PubMed Articles listed on BioPortfolio]

Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial.

Few data are available for the efficacy of "triple therapy" with two long-acting bronchodilators and an inhaled corticosteroid in chronic obstructive pulmonary disease (COPD). We designed this study t...

Formoterol fumarate + glycopyrrolate for the treatment of chronic obstructive pulmonary disease.

chronic obstructive pulmonary disease (COPD) is characterized by a high disability and increasing mortality. Bronchodilators are the cornerstone of pharmacological treatment in COPD, while therapeutic...

A Two-Period Open-Label, Single-Dose Crossover Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Between Cimetidine and Inhaled Extrafine CHF 5993.

CHF 5993 is an extrafine 'triple therapy' combination of the long-acting muscarinic antagonist glycopyrronium bromide (GB), the long-acting β2-agonist formoterol fumarate (FF), and the inhaled cortic...

Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease.

A fixed-dose inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combination of extrafine beclometasone dipropionate and formoterol fumarate (BDP/FF) has been recently approved for use in chroni...

Evaluation of a Therapeutic Interchange from Fluticasone/Salmeterol to Mometasone/Formoterol in Patients with Chronic Obstructive Pulmonary Disease.

Combination treatment with an inhaled corticosteroid and long-acting beta2-agonist is among the many treatment options for chronic obstructive pulmonary disease (COPD) that has been shown to improve c...

Medical and Biotech [MESH] Definitions

A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

A subcategory of CHRONIC OBSTRUCTIVE PULMONARY DISEASE. The disease is characterized by hypersecretion of mucus accompanied by a chronic (more than 3 months in 2 consecutive years) productive cough. Infectious agents are a major cause of chronic bronchitis.

A condition associated with multiple episodes of sleep apnea which are distinguished from obstructive sleep apnea (SLEEP APNEA, OBSTRUCTIVE) by the complete cessation of efforts to breathe. This disorder is associated with dysfunction of central nervous system centers that regulate respiration. This condition may be idiopathic (primary) or associated with lower brain stem lesions; chronic obstructive pulmonary disease (LUNG DISEASES, OBSTRUCTIVE); HEART FAILURE, CONGESTIVE; medication effect; and other conditions. Sleep maintenance is impaired, resulting in daytime hypersomnolence. Primary central sleep apnea is frequently associated with obstructive sleep apnea. When both forms are present the condition is referred to as mixed sleep apnea (see SLEEP APNEA SYNDROMES). (Adams et al., Principles of Neurology, 6th ed, p395; Neurol Clin 1996;14(3):611-28)

Measurement of the volume of gas in the lungs, including that which is trapped in poorly communicating air spaces. It is of particular use in chronic obstructive pulmonary disease and emphysema. (Segen, Dictionary of Modern Medicine, 1992)

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