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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT00440687 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

Start date: January 2001
Phase: Phase 4
Study type: Interventional

Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown.This randomised double-blind placebo-controlled trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD recruited from general practice. Participants will have a clinical and spirometric diagnosis of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler) or an identical placebo inhaler. Patients will be monitored using diary cards for a year with 3 monthly follow-up visits at their general practice. The primary outcome measures will be exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs, health status, lung function and unscheduled care. We tested the hypothesis that withdrawal of ICS in this population would lead to an increased number of exacerbations, earlier onset of exacerbation, and a worsening of symptoms.

NCT ID: NCT00435760 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: February 2007
Phase: Phase 3
Study type: Interventional

This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.

NCT ID: NCT00435708 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD)

DISCO
Start date: February 2007
Phase: Phase 1
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is estimated to cost the health service close to £1 billion every year. Around 80,000 people in Northern Ireland suffer from COPD. COPD is clinically defined as a slowly progressive condition characterised by airflow limitation, which is largely irreversible. Chronic inflammation and oxidative stress are key components of the underlying pathological process resulting in airflow limitation. Dietary factors and nutrients that have antioxidant or anti-inflammatory properties are therefore of interest with respect to the aetiology of COPD. The antioxidant vitamins C, E and beta-carotene are all present in the lung milieu. Such antioxidants represent the lung's first line of defence against oxygen free radicals. Observational studies indicate that a low dietary intake of antioxidant nutrients, or foods rich in antioxidants (e.g. fruit and vegetables), is associated with decreased lung function and increased risk of COPD. To date, there have been no food-based dietary interventions investigating the effect of increased fruit and vegetable intake on COPD. The investigators propose to recruit people with mild to moderate COPD and low fruit and vegetable intakes (<=2 portions daily) and randomise them to one of two study arms for 12 weeks - either to increase fruit and vegetable consumption to at least 5 portions a day, or to follow their normal diet. Airway and systemic oxidative stress and inflammation will be assessed at baseline and post-intervention in order to determine if fruit and vegetables have the potential to alleviate the oxidative stress and airway inflammation associated with COPD.

NCT ID: NCT00430729 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

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

The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).

NCT ID: NCT00429156 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Non-invasive Ventilation Versus Sham Ventilation in Chronic Obstructive Pulmonary Disease (COPD)

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that continuation of non-invasive ventilation (NIV) at home after an episode of acute hypercapnic respiratory failure (AHRF) treated by NIV in COPD patients would reduce the likelihood of death and recurrent AHRF requiring NIV or intubation. The investigators designed this study in a way that recruited COPD patients would be started on home NIV or sham treatment after an episode of AHRF requiring acute NIV. The patients are acclimatised to NIV application after a few days of acute use. The investigators chose occurrence of life-threatening event (recurrent AHRF and death) as the primary endpoint.

NCT ID: NCT00424528 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

Start date: December 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT00424268 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

HELIOS
Start date: January 2007
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

NCT ID: NCT00422604 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: October 2006
Phase: Phase 2
Study type: Interventional

The safety, tolerability, pharmacokinetics and pharmacodynamics/efficacy profiles of two different doses of GSK233705 will be compared with 2 active comparators and placebo, all medication delivered via dry powder inhaler.

NCT ID: NCT00421122 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.

NCT ID: NCT00419744 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.