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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT01329029 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)

REACT
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects. Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.

NCT ID: NCT01328444 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444. Study A

COPD
Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI)

NCT ID: NCT01327456 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

The Effects of a Self-management Intervention on Low Literacy Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: January 2008
Phase: N/A
Study type: Interventional

Purpose: To determine the role health literacy plays in the care continuum for Chronic Obstructive Pulmonary Disease (COPD) and the effect of a self-management intervention on inhaler technique use, time spent on self-management, and knowledge for COPD patients with low literacy. Participants: The investigators will recruit patients from the University of North Carolina at Chapel Hill Ambulatory Care Center (ACC) who have a diagnosis of COPD. Procedures (methods): Potential subjects with COPD will be identified through pharmacy claims data, clinic billing data and the electronic medical record. Eligibility will be prescreened by a research assistant (RA) using the electronic medical record prior to approaching potential subjects for consent. For the first part of the study, consenting subjects will complete a baseline health literacy assessment, a questionnaire, an inhaler technique assessment, and a diary of time spent in self-management activities. Pulmonary function tests (PFT) will be performed on all participants for whom PFTs have not been conducted within the previous 12 months. The questionnaire will include measures of COPD-related knowledge, self-management techniques, quality of care, access, quality of life, costs, healthcare utilization, exacerbations, and basic demographic information. The inhaler technique assessment will be administered by the research assistant using a pre-established protocol. The research assistant will abstract additional data from the medical record to assess the quality of care based on adherence to recommended COPD care guidelines. For the second part of the study, participants will be randomized to control and intervention arms. The self-management intervention will be an interactive experience, delivered by a trained research assistant, targeting self-management skills (inhaler use, using an action plan, etc), smoking cessation, and exercise/pulmonary rehabilitation. Those randomized to the control group will receive usual care. All participants will return 2-4 weeks after the intervention for a follow-up assessment of inhaler technique, COPD-related knowledge, and time spent in self-management.

NCT ID: NCT01325948 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Cross-sectional Study to Investigate the Effects of Chronic Obstructive Pulmonary Disease on Daily Life Activities

COPD LIFE
Start date: March 2011
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the effects of Chronic Obstructive Pulmonary Disease (COPD) on daily life activities in patients with COPD and also to determine the socio-demographic profile, daily life style and needs of the patients with COPD.

NCT ID: NCT01323660 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B

COPD
Start date: March 16, 2011
Phase: Phase 3
Study type: Interventional

This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI).

NCT ID: NCT01323634 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease

Start date: March 18, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.

NCT ID: NCT01323621 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: March 18, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.

NCT ID: NCT01322594 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease

Start date: March 2011
Phase: Phase 1
Study type: Interventional

Phase I study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease (COPD).

NCT ID: NCT01321463 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination

Start date: May 2011
Phase: Phase 2
Study type: Interventional

PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.

NCT ID: NCT01320930 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Rehabilitation in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD)

Start date: January 2007
Phase: N/A
Study type: Interventional

The study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (COPD).