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Lung Diseases clinical trials

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NCT ID: NCT02207829 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease

Start date: September 1, 2014
Phase: Phase 3
Study type: Interventional

This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the run-in period, subjects who meet the randomization criteria will be randomized to receive UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day 168 (Visit 10). The total duration of subject participation in the study will be approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 7. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.

NCT ID: NCT02207452 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Helium-3 MRI Imaging Study in COPD

Start date: August 5, 2010
Phase: Phase 1
Study type: Interventional

This protocol describes the investigation of the use of hyperpolarised helium magnetic resonance imaging (MRI) in reflecting the regional differences in lung function of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients. Since finalisation of the original protocol, new medications for COPD have received Market Authorisation Approvals. Protocol Amendment 02 has been prepared to include these medications in the protocol eligibility criteria and restrictions for the study.

NCT ID: NCT02205255 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

BACE Trial Substudy 2 - FarmEc Substudy

FarmEc
Start date: August 1, 2014
Phase: Phase 3
Study type: Interventional

A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.

NCT ID: NCT02205242 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

BACE Trial Substudy 1 - PROactive Substudy

PROactive
Start date: September 2014
Phase: Phase 3
Study type: Interventional

A first sub-analysis of the BACE trial will address physical activity levels in a subgroup of the intervention study with portable validated activity monitors.

NCT ID: NCT02204202 Terminated - Lung Disease Clinical Trials

PET Assessment of Acute Lung Transplant Rejection

Start date: February 2014
Phase:
Study type: Observational

The purpose of this research study is to gain understanding of the basic responses of the lungs to inflammation and specifically if there may be a better way to detect graft inflammation using non-invasive methods as well as to determine the effectiveness of immunosuppressive treatment regimens in preventing acute rejection in lung transplant recipients.

NCT ID: NCT02203474 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), in Patients With Chronic Obstructive Pulmonary Disease

Start date: August 2014
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to demonstrate the superiority of tiotropium hydrofluoroalkane (HFA) breath actuated inhaler (BAI) to placebo HFA BAI following repeated, once-daily dosing.

NCT ID: NCT02203266 Completed - Asthma Clinical Trials

Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting

Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to: - Improved compliance with prescribed inhaler use - Improved technique of inhaler use - A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage. - An improvement in patient quality of life scores

NCT ID: NCT02202616 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)

POWER
Start date: August 27, 2014
Phase: Phase 4
Study type: Interventional

This is a single cohort, prospective post approval study conducted on patients with COPD in Canada. The study will enroll patients that have not responded to their current treatment of tiotropium alone, or who are on the fixed dose combinations fluticasone propionate/salmeterol. Only patients for whom the physician has decided to change treatment due to lack of efficacy will be eligible to be enrolled in the study. Also will evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium 50 mcg) in the management of patients.

NCT ID: NCT02201654 Completed - Clinical trials for Interstitial Lung Disease

Stylet vs No Stylet During EBUS TBNA

Start date: June 2014
Phase: N/A
Study type: Interventional

This research study compares two ways to biopsy lymph nodes in the chest using endobronchial ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted through the mouth into the large airways of the chest, allowing us to see (via ultrasound) and biopsy the lymph nodes in the chest. The purpose of this research study is to determine if the EBUS-TBNA procedure can be made simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an inner stylet that runs through the middle of the needle. Because many other biopsy needles (such as the needles used in breast biopsy and different types of lung biopsy needles) do not use an inner stylet, the investigators do not think the use of a stylet is necessary. If this step can be safely eliminated without decreasing the effectiveness of the procedure, this could shorten the procedure (saving time). This study is deigned to formally test the hypothesis that a stylet is not necessary in EBUS-TBNA.

NCT ID: NCT02200549 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD

Start date: December 2014
Phase: N/A
Study type: Interventional

Chronic Obstructive Pulmonary Disease (COPD) ,the fourth leading cause of death in the world, represents an important public health challenge. It is also a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently, pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea, increase exercise capacity, and improve quality of life. Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of the best available means of improving muscle function in COPD.The most commonly form is cycle training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient with COPD. There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle training and cycle training. This study will evaluate the effects of combined inspiratory muscle training and cycle training in patients with COPD.