View clinical trials related to Chronic Disease.
Filter by:The objective of this study was to compare the bronchodilator efficacy and safety of ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation Aerosol in COPD patients
This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.
Purpose of the study - The purpose of this study is to develop and evaluate the efficacy of a new, theoretically based intervention to improve medication adherence in persons with HF. The hypotheses include: Hypothesis I. Poorly adherent patients with symptomatic HF who receive the intervention (n=40) will be more adherent to medicines during the12-month intervention than a control group (n=40) of poorly adherent patients with symptomatic HF. Hypothesis II. Poorly adherent patients with symptomatic HF who receive the intervention (n=40) will have fewer hospital readmissions (HR) and emergency department (ED) visits during the 12-month intervention than a control group of poorly adherent patients with symptomatic HF. Study Activities and population - A prospective, randomized controlled design will be used to pilot test the efficacy of a new intervention to promote adherence to the medication regimen in chronic heart failure in the clinical setting. The initial development and feasibility testing of the intervention is complete (Preliminary Work, Section 4.5). Patients with HF symptom exacerbation (n = 80) who exhibit high likelihood of poor adherence, as determined by a validated screening measure, the Medication Adherence Scale (MAS)89 at baseline assessment, will be recruited and randomized to receive the intervention or usual care with attention control. Medication adherence, symptom frequency and intensity, hospital readmissions (HR) and emergency department (ED) visits will be assessed in both groups at 3, 6 and 12-month clinic visits. The intervals between visits are considered sufficient to minimize sensitization bias to psychometric measures. Longitudinal measurement is required to evaluate the magnitude of change in adherence and symptom-related events occurring over time. Efficacy will be measured as improved adherence (primary outcome) and decreased HR and ED visits (secondary outcomes) in the intervention group as compared to the attention control group at 12 months. The study will close when all patients have had a 12-month post-enrollment clinic visit. Data Analysis & Safety/Risk Considerations - The investigators will use generalized linear models to test the primary and secondary hypotheses (McCullagh and Nelder, 1989). Logistic generalizations of the traditional, multivariate GLM are appropriate when the dependent variable is binary and the probability of an event is modeled, as is the case with adherence in this study. When the dependent variable is a count, a commonly used generalized model uses the natural logarithm of the count, as with re-hospitalizations and ED visits in this study. In compliance with NIH guidelines for data safety and monitoring activities, a number of quality control steps will be used to ensure the on-going safety of participants and the scientific integrity of this feasibility intervention study. The proposed study poses only very minimal risks to participants. All participants will receive usual care. Participation in the study will not replace patients' regular health care attention. Data safety will be monitored by the PI, the Data Safety Officer (Dr. Karl Swedberg), and the study co-investigators. Any adverse events will be reported immediately to the Duke IRB and the NIH. Data Safety. First, a project database will be constructed, using participant ID numbers and including all demographic, pre- and post-intervention history and all assessment materials. A separate file, cross-referencing participant identification with project ID numbers, will be maintained with access limited to the PI or a designated member of the investigative team.
This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.
This is a multicenter, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of the addition of UMEC (62.5 microgram[mcg]) when administered once-daily via dry powder inhaler (DPI) to Inhaled corticosteroid/ Long-acting beta2-agonist (ICS/LABA) twice-daily compared with placebo via DPI added to the ICS/LABA therapy over a treatment period of 12 weeks in subjects with COPD. This study is designed to investigate the addition of UMEC to ICS/LABA combinations at approved doses and frequencies for the treatment of COPD including SERETIDE™ 500/50 mcg twice daily, Fluticasone Propionate/Salmeterol Combination (FSC) 500/50 twice daily generic products such as AIRFLUSAL FORSPIRO inhaler 500/50 mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50 mcg twice daily and SYMBICORT TURBUHALER inhaler at doses of 200/6 mcg twice daily and 400/12 mcg twice daily, over 12 weeks in subjects with COPD. Albuterol/salbutamol metered-dose-inhaler (MDI) or nebules will be issued throughout the study for use as-needed (prn). Subjects who meet the eligibility criteria will be randomly assigned to one of the following blinded study treatment regimens in equal proportion (1:1): UMEC 62.5 mcg once-daily and Placebo once-daily. Approximately 230 subjects (115 subjects per treatment) will be randomized in order to complete at least 206 evaluable subjects. The total duration of the study will be approximately 14 weeks for each subject. UMEC is a Long-acting Muscarinic Antagonist (LAMA) currently under development as a monotherapy, as a combination product with a LABA, vilanterol (VI), for the treatment of COPD, and as a combination product with an ICS, fluticasone furoate (FF), for the treatment of asthma. The UMEC/VI combination 62.5/25 .mcg once-daily has been approved in the United States (U.S.) and Canada for COPD under the trade name ANORO™ ELLIPTA™ and is under regulatory review in other countries. SERETIDE, ANORO, and ELLIPTA are trade marks of the GlaxoSmithKline Group of Companies. Other company or product names mentioned herein may be the property of their respective owners.
Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils and specific inflammatory markers in patients with clinically well-defined moderate chronic obstructive pulmonary disease (COPD)
Study to investigate the effect of 12-week treatment with three doses (5, 25 and 75 mg) BIIL 284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety in patients with chronic obstructive pulmonary disease (COPD)
The primary objective is to investigate the efficacy of resveratrol on mitochondrial function in patients with COPD. The secondary objective is to investigate the effect of resveratrol on body composition, inflammatory status and mechanistic markers in blood, adipose and muscle tissue as well as a comprehensive assessment of metabolicand physical performance profile known to be affected by resveratrol.
Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler
Study to investigate the dose-dependent bronchodilator effect and the safety of single inhalation doses of BEA 2180 inhaled via Respimat® compared to placebo in patients with stable Chronic Obstructive Pulmonary Disease (COPD)