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

CHIESI0 sites30 target enrollmentOctober 3, 2006

ConditionsChronic Obstructive Pulmonary Disease MedDRA version: 6.1Level: PTClassification code 10053420

DrugsSERETIDE

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: CHIESI
Enrollment: 30
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 3, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

CHIESI

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.