Reversal of steroid insensitivity in COPD by theophylline

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: EUCTR2006-003561-13-GB
• Lead Sponsor: imperial college

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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