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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT01388920 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting

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

A significant proportion of COPD subjects experience muscle wasting, which has been associated with increased morbidity, impaired physical functioning, and a poor quality of life. Muscle wasting is associated with reduced muscle strength in COPD subjects. In particular, weakness of peripheral muscles has been reported to play an important role in the reduced functional capacity and impaired exercise performance. The primary objective of this study is to investigate the effect of tesamorelin, in conjunction with exercise training, on lean body mass measured by dual energy x-ray absorptiometry (DXA) scan.

NCT ID: NCT01388218 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)

Start date: July 2011
Phase:
Study type: Observational

The purpose of the protocol is to develop final draft PRO instruments of physical activity in daily life to be used and evaluated in the further validation studies measuring physical activity in chronic obstructive pulmonary disease (COPD) patients.

NCT ID: NCT01387230 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD

Start date: July 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation Powder is safe and effective compared with placebo or no active drug intake, when administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT01387178 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease

Start date: July 2008
Phase: N/A
Study type: Observational

Chronic obstructive pulmonary disease (COPD) is characterized by chronic airflow limitation caused by inflammation-mediated damage to lung tissue. Although damage to lung tissue in COPD appears to be irreversible, evidence suggests that the course of COPD can be altered through measures such as smoking cessation, pulmonary rehabilitation, and the use of pharmacotherapy for bronchodilation. A primary goal of maintenance pharmacotherapy is to reduce the incidence of acute exacerbations and the associated hospitalizations and emergency department (ED) visits. Bronchodilation in COPD maintenance therapy can be accomplished with the long-acting anticholinergic tiotropium (TIO), long acting beta-agonists (e.g. formoterol, salmeterol), methylxanthines (e.g. theophylline), or combination therapy with a long-acting beta-agonist and an inhaled corticosteroid (e.g. fluticasone propionate/salmeterol [FSC]). The objective of this study is to compare the benefits of combination long-acting beta-agonist/inhaled corticosteroid therapy to long-acting anticholinergic therapy. The study compares the risk of COPD exacerbations and COPD-related healthcare utilization and costs for commercially-insured patients age 40 and older who were prescribed FSC to those prescribed TIO. The null hypothesis is that no difference exists between the costs and outcomes of COPD patients treated with TIO and those treated with FSC. The test hypothesis is that patients treated with either TIO or FSC will incur lower costs and use fewer healthcare resources for the management of COPD. The source of data for this study was the Ingenix Impact database (formerly the Integrated Healthcare Information Services [IHCIS] database). This is an administrative claims database that includes patient-level data on enrollment, facility, professional, and pharmacy services from approximately 50 million patients covered by more than 40 managed care health plans across the United States (US). The study design is a retrospective cohort study.

NCT ID: NCT01385696 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients

Start date: June 2011
Phase: Phase 3
Study type: Interventional

Preference study: Genuair vs HandiHaler inhalers in COPD patients.

NCT ID: NCT01384981 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Effects of Non-invasive Ventilation on Rehabilitation Outcome in COPD-patients

Start date: January 2011
Phase: N/A
Study type: Interventional

The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.

NCT ID: NCT01382368 Enrolling by invitation - Clinical trials for Chronic Obstructive Pulmonary Disease

Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients

Start date: September 2011
Phase: Phase 4
Study type: Interventional

- Pulmonary diseases are increasingly important causes of morbidity and mortality in the modern world. - Sildenafil, an orally administered a phosphodiesterase type 5 (PDE-5) inhibitor, targets the nitric oxide (NO) pathway. The drug was first approved for the treatment of Pulmonary Arterial Hypertension (PAH) in 2005. - The aim of the suggested study is to examine the acute effect of oral intake of sildenafil on exercise tolerance and functional capacity in Chronic Obstructive Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis (IPF) and post Pneumonectomy patients. - The investigators hypothesize that oral ingestion of sildenafil prior the exercise may enhance exercise tolerance and improve function in COPD, IPF and post Pneumonectomy patients. - Patients and Methods: Sixty chronic lung disease patients males and females (aged 30 to 90 years) 20 COPD (GOLD III-IV) [9, 39] , 20 IPF and 20 post Pneumonectomy patients will be recruit to this study. - All subjects will carried out two maximal cardiopulmonary exercise tests (CPET) on bicycle ergometer in different days; 60 min after intake of placebo and 60 min after intake of 100 mg sildenafil (Pfizer, Sandwich, UK), in random order. - In first meeting prior exercise test at rest standard pulmonary function test, diffusion of CO, TLC and RV will be measured. In addition, Doppler Echocardiography and blood samples for NT-proBNP will be taken prior and post each CPET. - After 15-20 minute of passive recovery post exercise test all patients will perform 3 short functional tests including 6 minute walk test to assess functional capacity.

NCT ID: NCT01381471 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: August 2009
Phase: N/A
Study type: Observational

The specific aim of this study is to describe 1 year Advair dispensing rates for patients with COPD, and to measure the association between Advair adherence and healthcare utilization (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat are adherent versus those that are not.

NCT ID: NCT01381458 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Risk of Re-Hospitalization in Patients With Chronic Obstructive Pulmonary Disease (COPD) Post Exacerbation

Start date: September 2010
Phase: N/A
Study type: Observational

This retrospective database study will assess differences in the risk of re-hospitalization and other COPD-related exacerbations and costs for patients receiving fluticasone propionate/salmeterol xinafoate combination 250/50 (FSC) versus anticholinergics [i.e. tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium - IPR)] post-hospitalization or Emergency Department (ED) visit for the treatment of COPD. This is a hypotheses testing study. Associations are compared between FSC and AC cohorts. Hypotheses for the primary outcome and key secondary outcomes are presented below: Specifically the study hypotheses for the primary outcome being tested were: Ho: There is no difference in risk of COPD-related hospitalization between FSC and AC Ha: There is a difference in risk of COPD-related hospitalization between FSC and AC Hypothesis for the key secondary outcome of COPD-related costs that was tested was: Ho: There is no difference in COPD-related costs between FSC and AC Ha: There is a difference in COPD-related costs between FSC and AC

NCT ID: NCT01381406 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Impact of Initiating Tiotropium Alone Versus Initiating Tiotropium in Combination With Fluticasone Propionate/Salmeterol Xinafoate Combination (FSC) on Chronic Obstructive Pulmonary Disease-related Outcomes in Patients With Pre-existing Exacerbations

Start date: July 2008
Phase: N/A
Study type: Observational

This was a retrospective cohort design using administrative claims data from Jan 1, 2003 through Sep 30, 2007, representing the years of available data, were used for this study. Managed care enrollees having at least one pharmacy claim for tiotropium (TIO) during the study period were identified as the target population. An index TIO prescription was defined as the first chronologically occurring pharmacy claim for TIO during the period Jan 1, 2004 to Aug 31, 2006, called the enrollment period. The date of the index TIO prescription was termed as the index Rx date, and the 1-year period before the index Rx date was termed as the pre-index period. The period after the index date was termed as the post-index date, and is further divided into a 30-day combination assessment period and a 1-year follow-up period. COPD clinical and economic outcomes were measured in a variable length follow up period. The combination assessment period, defined as the 30-day period following the index Rx date, was used to categorize patients into 2 cohorts: TIO alone or TIO + FSC (fluticasone propionate/salmeterol xinofoate combination) depending on whether they use FSC in combination with TIO during this period. Combination therapy with TIO + FSC was defined as having an FSC claim on the same date as the TIO claim or a TIO and FSC pharmacy claim with overlapping days supply occurring within 30 days of index Rx date. Enrollees adding FSC for the first time after the 30-day combination assessment period were excluded from the sample, thus ensuring that the TIO-alone cohort is not using FSC. No outcomes were assessed in the 30-day combination assessment period. The 1-year period after the end of the 30-day combination assessment period was termed as the follow-up period and was used to assess all study outcomes. Enrollees were required to be continuously eligible in their health plans during the pre-index and post-index periods for a total of 25 months. An intent-to-treat approach was used for the analyses. Thus, patients identified to be in a drug therapy cohort were considered to be using that therapy during the entire follow-up period, regardless of therapy discontinuations. Specifically the study hypothesis for the primary outcome being tested was: Ho: There is no difference in risk of any COPD-related exacerbation between TIO+FSC and TIO cohorts Ha: There is a difference in risk of any COPD-related exacerbation between TIO+FSC and TIO cohorts Hypothesis for the key secondary outcome of COPD-related costs that was tested was: Ho: There is no difference in COPD-related costs between TIO+FSC and TIO cohorts Ha: There is a difference in COPD-related costs between TIO+FSC and TIO cohorts