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Lung Diseases clinical trials

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NCT ID: NCT01131806 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: December 2009
Phase: Phase 4
Study type: Interventional

Chronic obstructive pulmonary disease is characterized as inflammatory airway with not fully reversible airflow limitation.Combination treatment with inhaled corticosteroid (ICS) and long-acting β2 agonists (LABA)attains an improved control of symptoms and lung function, that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

NCT ID: NCT01128634 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Pharmacokinetic and Safety of GSK573719 and GW642444 Administered Individually and Concurrently, With Verapamilin in Healthy Subjects

Start date: March 4, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if the Pharmacokinetics and the Safety Profile of GSK573719 and GSK573719/GW642444 are effected by concurrent dosing with the PGP inhibitor verapamil.

NCT ID: NCT01126437 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

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

Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.

NCT ID: NCT01126047 Completed - Lung Diseases Clinical Trials

Exhaled Carbon Monoxide (eCO) for Diffusing Capacity (DLCO) Correction

Start date: May 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to check the accuracy of a procedure called exhaled carbon monoxide (eCO) testing. Exhaled carbon monoxide is used by physicians to help assess breathing in people with conditions like asthma and emphysema. eCO may be used to correct another breathing test (called diffusing capacity, or DLCO). Blood collection is usually required to correct the DLCO, so validation of the eCO test may help avoid that blood collection.

NCT ID: NCT01124422 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Fluticasone Propionate/Salmeterol Combination 250/50 DISKUS in the Exercise Endurance Time in Patients With Chronic Obstructive Pulmonary Disease

ESWT
Start date: July 19, 2010
Phase: Phase 4
Study type: Interventional

The objective of this study is to demonstrate that, when added to tiotropium (TIO), fluticasone propionate/salmeterol combination (FSC) DISKUS 250/50 significantly increases exercise endurance time (EET) in the endurance shuttle walk test (ESWT), compared to TIO alone. Male and female subjects at least 40 years of age with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) are eligible. Subjects will be screened and consented at or during a 6-week (wk) period prior to visit (V)1. The 4-wk run-in period begins immediately after V1, when subjects receive open-label TIO plus as-needed relief inhaler (identical formulations called albuterol in the US and salbutamol in Canada). At V2, subjects will perform an incremental shuttle walk test (ISWT) to establish their maximal walk response. The first ESWT will occur at V3. Subjects must demonstrate an EET of ≤20 min that is reproducible (EET from V3 and V4 varying by ≤2 min). Eligible subjects are then randomized at V5 to either FSC 250/50mcg DISKUS twice daily plus open label TIO 18 mcg daily, or placebo DISKUS twice daily plus open label TIO 18 mcg daily for the 4-wk treatment period. The last study visit is V6. The primary efficacy measure is the difference between the EET at V6 (wk-8) vs. V4 (wk-3; the last ESWT done before randomized study drug is given). Secondary efficacy measures include V6 vs. V4 comparisons in exercise dyspnea scale (EDS), exercise inspiratory capacity (EIC) and cardio-respiratory measurements (CRM), and V6 vs. V5 comparisons in dyspnea related to activities of daily living (baseline dyspnea index and transition dyspnea index interviewer-administered [BDI-TDI]) and quality of life (Chronic Respiratory Disease Questionnaire Self-administered Standardized [CRQ-SAS]). The safety measure will be an assessment of adverse events. We will also attempt to validate prospectively the minimal clinically-important difference (MCID) for a change in the EET through correlation with dyspnea and quality of life results.

NCT ID: NCT01120717 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Assess the Long-term Safety of QVA149

ENLIGHTEN
Start date: April 2010
Phase: Phase 3
Study type: Interventional

The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

NCT ID: NCT01120691 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations

SPARK
Start date: April 2010
Phase: Phase 3
Study type: Interventional

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.

NCT ID: NCT01120574 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypercapnic Response

Start date: October 2005
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the clinical benefits of home mechanical ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen administration. We will include clinically stable COPD patients with hypercapnic CRF who develop a nocturnal hypercapnic response to oxygen (PaCO2 increase on awakening, at night with oxygen, >10 mmHg respect to PaCO2 breathing room air and awake). Obstructive sleep apnoea syndrome (OSAS) will previously have been excluded. Patients will be admitted to the Pneumology ward where a nocturnal pulsioxymetry breathing oxygen therapy will be performed. Arterial blood gas samples will be taken at awakening (7AM). Patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment groups: - Oxygen therapy group - Home mechanical ventilation plus oxygen therapy group Home mechanical ventilation will be performed with a bilevel pressure ventilator. Functional respiratory variables as well as quality of life and sleep at onset and after 6 months treatment will be compared. The principal outcome will be the evolution of arterial blood gases (PaCO2) between the two groups.

NCT ID: NCT01120093 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

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

The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

NCT ID: NCT01119950 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.