TWICS - Theophylline with Inhaled Corticosteroids

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 16.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-001490-25-GB
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1424

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

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