View clinical trials related to Chronic Asthma.
Filter by:Asthma and chronic obstructive pulmonary disease (COPD) are common lung. Despite the important progresses achieved in treatments, the majority of affected patients suffer from severe symptoms and tend to be frequently hospitalised due to exacerbation. Reasons for uncontrolled asthma and COPD are manifold, but often a poor inhalation technique and a poor following of the prescribed treatment plan is observed, which is called non-adherence. The primary aim of this study will therefore be to measure medication adherence in patients with chronic obstructive lung diseases, and to investigate the impact of an audio reminder on disease outcomes and quality of life. The investigators hypotheses will be that an adherence reminder, improve medication adherence and that a good medication adherence elongate the time to next exacerbation in patients with chronic obstructive lung diseases. A prospective single-blind randomized controlled study is planned, where the investigators are going to analyse the adherence over a period of six months of in- and outpatients, who have experienced at least one exacerbation during the last year. The adherence of intervention- and control group will be measured by specific electronic data capture devices which can save each actuation with date and time. Patients assigned to the intervention group will be reminded for the inhalation by an audio reminder and will receive support calls if medication will not be taken as prescribed or if rescue medication will be used too often. In contrast, the control group, will not be reminded and will not receive any calls, if do not comply with the prescribed medication schedule or if they use their rescue medication too frequently. During study period, participants will be assessed every two months. Each assessment will include spirometry, measurement of diffusion capacity, exhaled nitric oxide and carbon monoxide. Moreover participants will demonstrate their inhalation techniques by using placebo devices and fill out questionnaires regarding quality of life. Statistical significance will be acquired if a p value of less than 0.05 is attained. Time to next exacerbation will be compared using the Kaplan-Meier method and Cox proportional hazard model. Results will be reported as HR (hazard ratio) with corresponding 95% confidence interval (CI) and p-value. "Time to next exacerbation" is subject to the investigators power calculation. A previous study has shown that 30% of COPD patients are readmitted again within six month because of an exacerbation. The investigators expect that 12% of patients in the intervention group will have an exacerbation. This corresponds to a hazard ratio of 0.36. Assuming a sample size of 70 subjects for each study group, there is a power of 80% to detect a HR of 0.36 based on a one-tailed test. Additional 14 subjects (7 for each study group) have been added to account for drop outs. Therefore, 154 subjects will be investigated in this study.
Cysteinyl leukotrienes (cys-LTs) are lipid inflammatory mediators that abound in mucosal inflammation and play a validated role in the pathogenesis of human asthma. It has recently been demonstrated that the platelet adenosine diphosphate (ADP) receptor, P2Y12, is required for LT4-mediated pulmonary inflammation and could be a novel potential therapeutic target for asthma. Thienopyridines (such as ticlopidine and clopidogrel) are pro-drugs, with proven antithrombotic efficacy, whose active metabolites selectively inhibit the platelet P2Y12 receptors. One of the drawbacks of thienopyridines is the high inter-individual variability in pharmacological response, mostly due to the high inter-individual variability in the capacity of transforming the pro-drug in its active metabolite. Prasugrel is a new member of the class of thienopyridines, with faster onset of action and a more uniform inhibition of platelet function compared to the other thienopyridines. Primary objective of our study will be to test whether or not the inhibition of the platelet P2Y12 receptor by prasugrel reduces the bronchial hyper-reactivity in patients with chronic asthma. The investigators designed a randomized, double blind (Subject, Caregiver, Investigator, Outcomes Assessor), crossover, placebo-controlled, prospective study, which will enroll 26 patients. Randomization will be performed in sequential blocks. Patients will be blindly and randomly allocated to treatment A (prasugrel 10 mg daily) or B (placebo) for 15 days. After a 15-day wash-out period, patients who had initially been allocated to treatment "A" will be allocated to treatment "B", and vice versa. Measurements will be done at baseline and on day 15 after each treatment, at the same time (+/- 1 h) of the day. Primary efficacy measure will be changes in airway hyper-responsiveness, recorded as reduction of FEV1 using the mannitol test induction. Secondary efficacy measures will be changes in markers of airway inflammation in sputum, changes in measurement of nitric oxide expiration (as surrogate marker of airway lung inflammation), count of eosinophil granulocytes in peripheral blood smear, changes in asthma exacerbation rates and symptom scores. Changes in phosphorylation of platelet VASP (Vasodilator-stimulated phosphoprotein) by ADP, measured with a flow cytometric technique, will be used as markers of the degree of inhibition of platelet P2Y12 receptors attained in each subjects by treatment with prasugrel.
This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.