Enhancement of in-Vitro GC Function in Patients With COPD
Condition: COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: Fluticasone Propionate; placebo; Theophylline
Intervention description: 500 u; Theophylline placebo capcule
Intervention MeSH terms: Fluticasone; Xhance; Theophylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

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.
    

Eligibility 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