A randomised, double-blind placebo controlled trial of the effectiveness of low dose oral Theophylline as an adjunct to Inhaled CorticoSteroids in preventing exacerbations of chronic obstructive pulmonary disease (COPD)

niversity of Aberdeen (UK)0 sites1,578 target enrollmentSeptember 19, 2013

Overview

Registry

who.int

Start Date

September 19, 2013

End Date

September 1, 2017

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Aberdeen (UK)

•1\. Aged 40 years
•2\. A smoking history of at least 10 pack years
•3\. An established predominant respiratory diagnosis of COPD (post bronchodilator FEV1/FVC\<0\.7\)
•4\. Current use of ICS therapy (irrespective of long\-acting beta agonist (LABA) and/or long\-acting anticholinergic agent (LAMA) use)
•5\. A history of at least two exacerbations requiring treatment with antibiotics and/or oral corticosteroid in the previous year, based on patient report
•6\. Clinically stable with no COPD exacerbation for at least 4 weeks
•7\. Able to swallow study medication
•8\. Able and willing to give informed consent to participate
•9\. Able and willing to participate in the study procedures, undergo spirometric assessment, complete study questionnaire
•Target Gender: Male \& Female; Lower Age Limit 40 years

•1\. Severe or unstable ischaemic heart disease
•2\. A predominant respiratory disease other than COPD
•3\. Any other significant disease/disorder which, in the investigator?s opinion, either puts the patient at risk because of study participation or may influence the results of the study or the patient's ability to participate in the study
•4\. Previous allocation of a randomisation code in the study or current participation in another interventional clinical study
•5\. Theophylline use currently
•6\. Known or suspected hypersensitivity to theophylline
•7\. Current use of drugs known to interact with theophylline and/or increase serum theophylline: antimicrobials: aciclovir, clarithromiycin, ciprofloxacin, erythromycin, fluconazole, ketoconazole, levofloxacin, norfloxacin; cardiovascular: diltiazem, mexiletine, pentoxifylline, verapamil;neurological: bupropion, disulfiram, fluvoxamine, lithium;hormonal: medroxyprogesterone, oestrogens; immunological: methotrexate, peginterferon alpha, tacrolimus; miscellaneous: cimetidine, deferasirox, febuxostat, roflumilast, thiabendazole
•8\. For women, current pregnancy or breast\-feeding, or planned pregnancy during the study