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Lung Diseases clinical trials

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NCT ID: NCT02014480 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Cross-Over Study to Evaluate Lung Function Response After Treatment With Umeclidinium (UMEC) 62.5 Micrograms (mcg), Vilanterol (VI) 25 mcg, and Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 mcg Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: February 1, 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, 3-way crossover study to evaluate the lung function response to UMEC 62.5 mcg, VI 25 mcg, and UMEC/VI 62.525 mcg, administered once-daily via a novel dry powder inhaler (NDPI) over 14 days in subjects with COPD. The study consisted of Run in Phase (5 to 7 days), Treatment Phase (made up of 3 treatment periods of 14 days each separated by 10 to 14 days Washout Period) and Follow-up Phase (7 to 9 days after completion of final visit or premature discontinuation). Eligible subjects will be randomized to a sequence of UMEC 62.5 mcg, VI 25 mcg, and UMEC/VI 62.5/25 mcg such that all subjects will receive each treatment. Serial spirometry assessments will be conducted on Day 1 and Day 14 and trough spirometry will be conducted on Day 2 and Day 15 of each treatment period. On Day 1 and 14 of each treatment period vital signs will be assessed and adverse event (AE)s will be recorded throughout the total duration of the study (approximately 12 weeks).

NCT ID: NCT02014155 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD

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

Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ® through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles, the chief of these being the diaphragm which is which objectified the improvement of its function . To monitor the action of the respiratory muscles can be used several tools such as manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles, or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of 45 individuals obtained by random convenience and divided into three groups, COPD participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength, lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at baseline. Hypothesis: 1. The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP) in COPD patients regardless of whether they are enrolled in a program of pulmonary rehabilitation (PR). 2. TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program. 3. Patients with COPD who do not participate in a PR program have higher handgrip strength compared to patients who did not participate in a PR program. 4. There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI. 5. TMI in COPD patients participating in a program RP produces greater increase in MIP, the handgrip strength, improves breathing pattern and a greater reduction in the activity of the SCM muscle and diaphragm than in those who did not participate in a program RP. 6. There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood pressure and increased oxygen saturation at the end of the TMI. 7. TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.

NCT ID: NCT02007772 Completed - Clinical trials for COPD Chronic Obstructive Pulmonary Disease

Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients

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

The purpose of this trial ist to investigate the difference of the efficacy of two systems for breath support in patients with COPD.

NCT ID: NCT02006732 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)

Start date: November 2013
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.

NCT ID: NCT02006537 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly Subjects

Start date: January 31, 2014
Phase: Phase 1
Study type: Interventional

This study will investigate the safety and pharmacokinetics (PK) of a single dose of GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and age on drug exposure. The biliary metabolites in healthy young males will be investigated using the Entero-test after a single oral dose of GSK2256294. This study will be conducted in two cohorts (Cohort 1 and Cohort 2). Cohort 1 is open label in order to characterise the PK profile of GSK2256294 in healthy young males and also to investigate the biliary metabolites of GSK2256294. Cohort 2 uses a crossover design to allow comparison of the PK parameters of GSK2256294 between in the fed and fasted state within subject and also to compare the PK parameters of GSK2256294 between male and female subjects. A washout period of a minimum of 2 weeks has been chosen to allow and adequate washout of GSK2256294.

NCT ID: NCT02006082 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Readmissions to Hospital Among Patients With COPD After Telemedicine Video Consultation - a Pilot Project

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

The purpose of this study was to evaluate the effects of telemedicine video-consultation (TVC) on the frequency of hospital re-admissions during 12 months follow-up after TVC among patients with chronic obstructive pulmonary disease (COPD). Our secondary aims were to assess the impact of TVC on the length of recurrent hospital stays and time to re-admission within 12 months follow-up after TVC. We also wanted to evaluate the patient satisfaction related to TVC.

NCT ID: NCT02002351 Completed - Rehabilitation Clinical Trials

Prospective Study on Rehabilitation Patients With Pulmonary Hypertension and Other Pulmonary Diseases

Start date: December 2013
Phase: N/A
Study type: Observational [Patient Registry]

This monocentric registry should provide information on the extent how patients with pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment. The data may provide a basis for further prospective studies showing the treatment of patients with pulmonary diseases especially by physical activation.

NCT ID: NCT02001922 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Soins intégrés BPCO (Broncho-pneumopathie Chronique Obstructive) en Valais - Mieux Vivre Avec ma BPCO (COPD Integrated Care Program Valais - Living Well With COPD)

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

Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by acute exacerbations that contribute to physical impairment and increased healthcare use and costs. Given the increasing burden of this disease in terms of morbidity, disability, mortality and costs, innovative care models centered on patients and aiming at improving quality and comprehensiveness of care are needed. Effective implementation and evaluation of chronic disease management - integrated care(CDM-IC) programs, in the real world context is of great importance. Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility and effectiveness of a community-based CDM-IC program for COPD patients residing in the canton of Valais. Design: The evaluation plan of this study will combine both quantitative (controlled before-after study design) and qualitative methods (focus groups with COPD patients and practicing healthcare professionals). Setting: French-speaking part of the canton of Valais. Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease, non-institutionalized and residing in the canton of Valais. The control group of patients will be constituted of age and gender-matched COPD patients from the Swiss COPD cohort study. Measures: Quantitative part: Primary outcomes: Generic and disease-specific health-related quality-of-life and all-cause hospitalizations (past 12 months) Other outcomes: 1. Processes of care 2. Patients' assessment of how care is congruent with the Chronic Care Model (PACIC instrument) 3. Measure of self-efficacy (intermediary outcome) 4. 6-minutes walking test, nb of COPD exacerbations, % of current smokers 5. Healthcare utilization: unscheduled ambulatory care visits 6. Care satisfaction 7. Measures of the process of implementation of the intervention Qualitative part: At 12 months: conduct of two focus groups of participating COPD patients, and of two focus groups of participating healthcare professionals.

NCT ID: NCT01998724 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial

LEAP
Start date: August 2012
Phase: N/A
Study type: Interventional

The main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program.

NCT ID: NCT01989182 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

The Spiration Valve System for the Treatment of Severe Emphysema

REACH
Start date: November 8, 2013
Phase: N/A
Study type: Interventional

This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group. The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.