Enhancement of in-Vitro GC Function in Patients With COPD

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigator wish therefore to continue these studies on theophylline principally by conducting a small clinical pilot study on 20-30 COPD patients in a randomised, double-blind, placebo-controlled, parallel-group study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborators: Medical Research Council; Mitsubishi Tanabe Pharma Corporation
• Treatments: Fluticasone; Theophylline; Xhance

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 < 30% tend to have more severe symptom limitation and generally (though not always) find participation in a clinical trial involving 4 visits to the clinic difficult. Their airway disease is also generally less responsive to therapeutic intervention and as a consequence finding measurements which show changes to these therapeutic interventions is more difficult.

COPD patients

• All participants will be classified to Stage 2-3 of the GOLD (Global initiative for Obstructive Lung Disease) guidelines

• Male or female, aged 45-80 years (according to GOLD guidelines)

• 30% < FEV1 < 80% predicted

• FEV1/FVC < 70%

• Cigarette exposure of >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

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 participant 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 participant 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