DOUBLE BLIND, DOUBLE DUMMY, RANDOMISED, PARALLEL GROUP, MONOCENTRIC CLINICAL TRIAL ON THE EFFECTS OF CHF 1535 MDI OR SERETIDE DPI ON LUNG HYPERINFLATION AND EXERCISE TOLERANCE IN PATIENTS WITH COPD A PILOT STUDY - ND
- Conditions
- Chronic Obstructive Pulmonary DiseaseMedDRA version: 6.1Level: PTClassification code 10053420
- Registration Number
- EUCTR2005-005857-23-IT
- Lead Sponsor
- CHIESI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Patients will be enrolled into the 2 weeks run-in period if they meet the following criteria Patients of either sex aged 40-70 years. Clinically stable patients with a diagnosis of COPD, according with the recommendations of the National Heart Lung and Blood Institute/World Health Organisation NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease GOLD 12 and satisfying the following -Post-bronchodilator FEV1 65 of the predicted normal values, and plethysmographic functional residual capacity 8805; 120 ; -FEV1/FVC ratio 70 . Positive partial response to the reversibility test in the screening visit, defined as an increase from baseline value of at least 5 but less than 12 of predicted normal value post-dosing minus pre-dosing/pre-dosing x 100 in the FEV1 measurement 30 minutes following 4 puffs 4 x 100 g of inhaled salbutamol pMDI. Current or past tobacco heavy smoking habits defined as smoking for 20 pack years, where 1 pack year 20 cigarettes/day for 1 year or equivalent . A cooperative attitude and ability to be trained to use correctly the pMDI and the Diskus inhaler. Written informed consent obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients will be not enrolled if they meet any of the following criteria Evidence of COPD exacerbation and/or symptomatic infection of the airways in the previous 4 weeks requiring antibiotic therapy. History or presence of clinically significant disease whose sequelae and/or treatments can interfere with the results of the present study. Presence of asthma or positive response FEV1 increase major or equal 12 and 200 ml after 400 mcg salbutamol to the reversibility test. Patients treated with more than 24 mcg daily formoterol or 100 mcg daily salmeterol Patients treated with more than four inhalations daily of Budesonide/formoterol 160/4,5 mcg combination or Fluticasone/salmeterol 125/25 combination or more than two inhalations from Fluticasone/salmeterol diskus 250/50. History or presence of chronic heart failure CHF , coronary artery disease, cardiac arrhythmias, severe hypertension, diabetes mellitus, impaired hepatic and/or renal function. History of myocardial infarction, cerebrovascular disease. Other haemodynamic relevant rhythm disturbances including atrial flutter or atrial fibrillation with ventricular response, bradicardia smaller or equal 55 bpm , evidence of atrial-ventricular block on ECG of more than 1st degree. History of percutaneous transluminal coronary angioplasty PTCA or coronary artery by-pass graft CABG . Evidence of posture and gait disturbances, or impairment of limb coordination due to any cause. Patients taking oral corticosteroids in the last month prior to study entry. History of hypersensitivity to symphatomimetic drugs. Patients taking beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors MAOI . Pregnant or lactating females or females at risk of pregnancy, i.e. those not demonstrating adequate contraception i.e. barrier methods, intrauterine devices, hormonal treatment or sterilization . A pregnancy test is recommended in fertile age women. Patients requiring long-term oxygen therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of beclomethasone plus formoterol combination in HFA versus seretide Diskus in the improvement of endurance time in adult patients with partially reversible COPD.;Secondary Objective: To assess the efficacy of the two drugs regimens on the following parameters static and dynamic pulmonary function tests, dyspnoea. To assess the safety profile of the two treatment tests.;Primary end point(s): ET measured 60 minutes post-dosing at the end of the 12 weeks treatment period
- Secondary Outcome Measures
Name Time Method