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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT01713335 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Proteasis Evaluation in COPD

Pro-BPCO
Start date: October 18, 2012
Phase:
Study type: Observational

The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients. Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be included: Healthy smoker subjects, stable COPD patients and COPD patients with acute exacerbation. Kallicrein levels in sputum will be compared in these groups.

NCT ID: NCT01713075 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for Long-term Use for Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: November 2012
Phase: N/A
Study type: Observational

The purpose of the investigation is to confirm the safety and efficacy in long-term use of Symbicort Turbuhaler in patients with Chronic obstructive pulmonary disease (COPD) under the post-marketing actual use.

NCT ID: NCT01712516 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

Start date: December 2012
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

NCT ID: NCT01709903 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149

Start date: November 2012
Phase: Phase 3
Study type: Interventional

To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD

NCT ID: NCT01709864 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

NVA237 Versus Placebo 12-week Efficacy Study

Start date: November 2012
Phase: Phase 3
Study type: Interventional

The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

NCT ID: NCT01708278 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Beneficial Effects of Quercetin in Chronic Obstructive Pulmonary Disease (COPD)

Quercetin
Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is a progressive disorder of the lung parenchyma and airways, which is the third-leading cause of death in the USA. Current therapies for COPD are only partially effective and may also have side effects. Although increasing evidence indicates that quercetin supplementation may be beneficial in treating COPD, key methodological issues have not been resolved. The overall objective of this study is to determine the dosage of quercetin supplementation, bioavailability of quercetin, safety, dose-response relationship and appropriate biomarkers which reflect clinical outcomes in patients with COPD that is necessary for conducting large clinical trials in this patient population.

NCT ID: NCT01706536 Completed - COPD Clinical Trials

A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

GOLDEN-2
Start date: October 2012
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.

NCT ID: NCT01706328 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: October 15, 2012
Phase: Phase 3
Study type: Interventional

This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects. Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subject's adherence with study treatment, study procedures and assessment of disease stability. At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period. A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks.

NCT ID: NCT01704404 Completed - COPD Clinical Trials

7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Start date: December 2012
Phase: Phase 2
Study type: Interventional

This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT01703624 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Dose Ranging Study of Glycopyrronium Bromide in Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease

Start date: May 2013
Phase: Phase 2
Study type: Interventional

This is an investigation of the beneficial effects, tolerability and safety of a range of single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long term and progressive disease of the lungs, generally caused by cigarette smoking, but other factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful in dilating the constricted airways of such patients, with a duration of action variously described as being between 12 and 24 hours. This study will investigate how well tolerated and safe this medication is at a range of doses. It will also help in the selection of a suitable dose for larger and repeat dose studies, based on measures of lung response. It will also help to determine how often the medication should be given; twice daily, or once daily. Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of age. Patients will be medically assessed before participation to ensure their suitability. The study will take place in one centre in the UK over five sessions; at each session one dose (2 puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple inhaler device. Neither staff nor patients will know which dose, or if placebo, is being taken. Lung function will be measured for up to 26 hours after the administration of each dose using standard spirometry equipment. Blood samples will be taken over a 24-hour period to check the blood levels of GB. There will be a period of about a week between each dosing session. Patients will be medically reviewed after the study to confirm that no untoward effects are present.