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Lung Diseases clinical trials

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NCT ID: NCT01704404 Completed - COPD Clinical Trials

7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Start date: December 2012
Phase: Phase 2
Study type: Interventional

This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT01703845 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.

Start date: October 2012
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Japanese patients with COPD.

NCT ID: NCT01703624 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Dose Ranging Study of Glycopyrronium Bromide in Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease

Start date: May 2013
Phase: Phase 2
Study type: Interventional

This is an investigation of the beneficial effects, tolerability and safety of a range of single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long term and progressive disease of the lungs, generally caused by cigarette smoking, but other factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful in dilating the constricted airways of such patients, with a duration of action variously described as being between 12 and 24 hours. This study will investigate how well tolerated and safe this medication is at a range of doses. It will also help in the selection of a suitable dose for larger and repeat dose studies, based on measures of lung response. It will also help to determine how often the medication should be given; twice daily, or once daily. Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of age. Patients will be medically assessed before participation to ensure their suitability. The study will take place in one centre in the UK over five sessions; at each session one dose (2 puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple inhaler device. Neither staff nor patients will know which dose, or if placebo, is being taken. Lung function will be measured for up to 26 hours after the administration of each dose using standard spirometry equipment. Blood samples will be taken over a 24-hour period to check the blood levels of GB. There will be a period of about a week between each dosing session. Patients will be medically reviewed after the study to confirm that no untoward effects are present.

NCT ID: NCT01703416 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Correlation Between Patient Perception and Findings on Clinical Examination in Chronic Obstructive Pulmonary Disease (COPD) Patients

RELIEF
Start date: October 2012
Phase: N/A
Study type: Observational

This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice the possible correlation between patient perception of the ability to perform morning activities and the physician's assessment during a regular physical exam in patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.

NCT ID: NCT01702363 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Long-term Safety Study for GSK573719 in Japanese

AC4115361
Start date: August 2012
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and tolerability of GSK573719 Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.

NCT ID: NCT01701869 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Microbiology & Immunology of the Chronically-inflamed Airway

MICA
Start date: September 2012
Phase: N/A
Study type: Observational

Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and the only one of the common causes that is still rising. The main effects of the disease are the destruction and inflammation of lung tissue rendering breathing difficult. COPD has significant effects on the quality of life of sufferers and the disease is predicted to be the fifth most common cause of disability in the world by 2020. Patients with COPD are prone to periods of worsening disease symptoms, known as exacerbations, which are often caused by viral and bacterial infections of the lung and current vaccines appear to have little efficacy in limiting these exacerbations. The loss of lung function caused by infectious exacerbations is irreversible and patients who frequently exacerbate experience more rapid disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species that colonises the airways and causes exacerbations in COPD. With the development of more sensitive molecular techniques it has been possible to ascertain that it is the acquisition of new strains of NTHi that correlate strongly with exacerbations. However, not all patients with COPD have NTHi in their lungs and the question remains as to why some COPD patients are susceptible to such infections. This study aims to answer this question by comparing the airways of COPD patients who are colonized by NTHi and those who are not to analyse whether the levels of protective antibodies in the lungs and the function of the immune cells in the NTHi colonized airway are reduced. Moreover, we aim to correlate this reduction in immunity with areas of lung damage ascertained by high resolution computed tomography. The aim of this research is to better understand this apparent deficiency in airway immunity as this is likely to impact on vaccine efficacy in COPD.

NCT ID: NCT01697696 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Long Term Safety Study of NVA237 vs QAB149 in COPD Patients

Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.

NCT ID: NCT01696916 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV

Start date: March 2012
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the development of partial pressure of carbon dioxide during the 6-min walking test and during night in Chronic Obstructive Pulmonary Disease (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide, oxygen saturation and the heart rate are registered by a device called "Sentec" during the mentioned periods. In addition a measurement of activity is realised by an activity monitor ("Sensewear").

NCT ID: NCT01696058 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Start date: September 2012
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.

NCT ID: NCT01695265 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Feel Breathe, Restriction Device Ventilatory Nasal (COPD)

BreatheCOPD
Start date: February 2012
Phase: N/A
Study type: Interventional

FEELBREATHE®, a nasal ventilatory restriction device, used during an exercise test in treadmill produces changes on breathing efficiency in patients with Chronic Obstructive Pulmonary Disease (COPD). 20 men with COPD with a forced expiratory volume in the first second between 30% and 70% of its predicted value were selected. Then, a maximal incremental cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters. During the second day, each participant conducted two tests with 30 min of rest between them. Exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at 50% of VO2peak. Each test was performed randomnly in two different conditions: 1) oronasal breathing (ONB); and 2) nasal breathing through the FB.