Chronic Obstructive Lung Disease (COPD)
Conditions
Interventions
Trade Name: Flixotide diskhaler 500
Product Name: fluticasone
Pharmaceutical Form: Inhalation powder
Pharmaceutical form of the placebo: Inhalation powd
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: COPD patients · All subjects will be classified to Stage 2-3 of the GOLD guidelines · Male or female, aged 45 –80 years · 30% 10 pack-years# · With or without chronic symptoms (cough, sputum production, dyspnea). · Steroid therapy will be stopped 2wks before run-in, but long acting bronchodilators are acceptable. · The subjects are able to give informed consent # The smoking history should include both the number smoked, for how long, and an estimate of total pack-years of smoking. One pack of 20 cigarettes smoked per day for 1 year = one pack year. Total pack years = No. cigarettes smoked per day/20 x no. years of smoking 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
Exclusion criteria: Any history or evidence of asthma · Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator · Hospital admission within the last 6 months · Upper respiratory infection within the last 4 weeks · Subjects who have received research medication within the previous one month · Subjects unable to give informed consent · Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study · Known or suspected hypersensitivity to study therapy or excipients · Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator · Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant · Any significant disease or disorder (e.g. gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) or abnormality laboratory tests which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patients ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): Sputum inflammatory cell counts.;Main Objective: Does the addition of low dose theophylline (a drug already commonly used in Chronic Obstructive Lung Disease - COPD) restore the putative anti-inflammatory effects (measured from in-vitro samples taken by inducing sputum production) of inhaled steroids in patients with COPD? | — |
Countries
United Kingdom
Outcome results
None listed