Theophylline With Inhaled CorticoSteroid (ICS)

Not Applicable

Completed

• Conditions: Topic: Primary Care Research Network for England, Respiratory; Subtopic: Not Assigned, Respiratory (all Subtopics); Disease: Respiratory, All Diseases; Respiratory; Chronic obstructive pulmonary disease, unspecified

• Registration Number: ISRCTN27066620
• Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26058585 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30326124 2019 results in: http://www.ncbi.nlm.nih.gov/pubmed/31343402 (added 26/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-19
• Study Completion: 2017-09-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1578

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified