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 - TWICS - Theophylline with Inhaled Corticosteroid

niversity of Aberdeen0 个研究点目标入组 1,424 人开始时间: 2013年8月13日最近更新: 2019年6月30日

试验速览

暂无简介。

•Aged = 40 years. • A smoking history of at least 10 pack years. • An established predominant respiratory diagnosis of COPD (post bronchodilator FEV1/FVC<0.7). • Current use of ICS therapy (irrespective of LABA and/or LAMA use). • A history of at least two exacerbations requiring treatment with antibiotics and/or oral corticosteroid use in the previous year, based on patient report. • Clinically stable with no COPD exacerbation for at least 4 weeks. • Able to swallow study medication. • Able and willing to give informed consent to participate. • Able and willing to participate in the study procedures; undergo spirometric assessment, complete study questionnaire.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 700
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 724

•Severe or unstable ischaemic heart disease. • A predominant respiratory disease other than COPD. • 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. • Previous allocation of a randomisation code in the study or current participation in another interventional clinical study. • Theophylline use currently. • Known or suspected hypersensitivity to theophylline. • 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. • For women, current pregnancy or breast-feeding, or planned pregnancy during the study.

发起方

niversity of Aberdeen