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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT00246935 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

Start date: May 2005
Phase: Phase 3
Study type: Interventional

The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is an extension of the 24-week study APTA-2217-06 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.

NCT ID: NCT00245661 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease

Start date: October 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease. The study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. In contrast, it may result in an beneficiary effect because it positively affects the sleep quality and sleep structure which may result in more alertness and less daytime sleepiness and less dyspnea during the day.

NCT ID: NCT00243282 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Randomized Controlled Trial of Mind-Body Breathing Therapy (in Chronic Obstructive Pulmonary Disease) To Improve Palliation of Dyspnea and Health-Related Quality of Life

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

Dyspnea (shortness of breath) is a complex experience that includes interpretation of physical impairments and associated distress to the person. The role of mind-body interactions in the experience of the symptom of dyspnea suggests that complementary and alternative medicine (CAM) therapies may be effective in abating dyspnea and improving patients' health-related quality of life. CAM strategies work in a number of ways that are directly applicable to dyspnea, such as decreasing the stress response, inducing relaxation, and facilitating a less distressful interpreted experience of physical disorders. We have combined a number of established CAM approaches aimed at breath-centered mindfulness and relaxation into an single therapy, mind-body breathing therapy (MBBT). The purpose of this study is to test the efficacy of MBBT in improving dyspnea and health-related quality of life for patients with emphysema (chronic obstructive pulmonary disease).

NCT ID: NCT00242320 Completed - COPD Clinical Trials

Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

Start date: August 2005
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.

NCT ID: NCT00242294 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

Start date: November 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily. The study duration consists of a baseline period (4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

NCT ID: NCT00239499 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Pilot Study Comparing Tiotropium (Spiriva) to Salmeterol (Serevent) Plus Fluticasone (Flixotide) in Chronic Obstructive Pulmonary Disease (COPD)

Start date: September 2003
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to estimate the comparative bronchodilator effect size and variability for tiotropium (Spiriva, 18 µg q.d.) with the free combination of salmeterol (Serevent, 50 µg b.i.d.) and fluticasone (Flixotide, 250 µg b.i.d.) in COPD patients. International COPD guidelines preserve milder stages of the disease (GOLD stage I and IIa) to bronchodilators and recommend the addition of inhaled corticosteroids only in those patients who have a documented spirometric response to inhaled corticosteroids and in patients with a post-bronchodilator FEV1 of less than 50% predicted, who suffer from frequent exacerbations requiring oral courses of corticosteroids. Recently published reports indicate that additional bronchodilator efficacy may be achieved when a long-acting beta agonist is combined with an inhaled corticosteroid. Steady state bronchodilation was achieved within one week with the drug combination. However, results of these studies are not consistent, and since the inclusion criteria employed were different from those utilised in the previously conducted tiotropium studies, it is difficult to generalise the observed effects to the general COPD population. In addition, no comparative data is available on the average response over the 12 daytime hours when COPD patients are active and in most need of bronchodilation. 12 hours corresponds to the dosing intervals for both salmeterol and fluticasone.

NCT ID: NCT00239434 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20g, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)

Start date: June 2003
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare the bronchodilator efficacy and safety of once daily dosing of tiotropium inhalation capsules (18 ?g) and Atrovent? MDI (2 puffs of ipratropium bromide 20 ?g four times daily) in patients with chronic obstructive pulmonary disease.

NCT ID: NCT00239421 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)

Start date: November 2003
Phase: Phase 4
Study type: Interventional

To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol plus fluticasone in COPD patients.

NCT ID: NCT00239278 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Budesonide / Formoterol in Treatment of Exacerbations of COPD

Start date: January 2001
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy

NCT ID: NCT00232674 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy Study of the Effect of Budesonide on Emphysema

Start date: July 1999
Phase: Phase 4
Study type: Interventional

To assess the effect of up to 4 years treatment with budesonide on progression of emphysema in patients with Chronic Obstructive Lung Disease.