Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Trade Name: flixotide diskhaler 500
Product Name: fluticasone
Pharmaceutical Form: Inhalation powder
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhal
Sponsors
imperial college
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants with COPD with an FEV1 of 80-30% predicted. This will incorporate the majority of participants with COPD seen within the chest clinic. Patients with an FEV1 > 80% predicted are not generally severe enough to warrant hospital follow up. These patients are also unlikely to have severe enough disease (and therefore airway inflammation) which may be modified by the therapeutic agents we are studying. Patients with an FEV1 10 pack-years# · With or without chronic symptoms (cough, sputum production, dyspnea). · Steroid therapy will be stopped before run-in, but long acting bronchodilators are acceptable. · The participants 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 with respiratory infection within the last 6 months · Upper respiratory infection within the last 4 weeks · Participants who have received research medication within the previous one month · Participants unable to give informed consent · Any mental condition rendering the participent unable to understand the nature, scope and possible consequences of the study · Known or suspected hypersensitivity to study therapy or excipients · Participants 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 participent at risk because of inclusion in the study, or may influence the results of the study, or the participants ability to take part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does the addition of low dose theophylline restore the anti-inflammatory effects of steroids?;Secondary Objective: ;Primary end point(s): sputum inflammatory cell counts | — |
Countries
United Kingdom
Outcome results
None listed