Microbiome Use to evaluate Safety of Inhaled Corticosteroids

Phase 1

• Conditions: Chronic Obstructive Pulmonary Diseae; MedDRA version: 20.0 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: EUCTR2016-000734-21-GB
• Lead Sponsor: niversity of Dundee & NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-24
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

•Male and female patients aged > 40 years
•Current or ex smokers having at least a 10 pack year smoking history
•A clinical diagnosis of COPD made by a physician with a post-bronchodilator FEV1/FVC ratio at screening of <70%
•Severe COPD according to consensus guidelines consisting of a post-bronchodilator FEV1 <50% predicted at screening and/or a history of 2 or more exacerbations in the previous year OR one hospital admission for an exacerbation of COPD in the previous year (equivalent to GOLD 2011 grade C/D)
•Able to perform all study procedures including spirometry and questionnaires with minimal assistance.

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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Inability to give informed consent
•Asthma (defined according to Scottish Intercollegiate Guidelines Network criteria) [29])#
•A primary diagnosis of bronchiectasis confirmed on computed tomography.(it is not necessary to perform a CT scan to exclude this if the patient has not previously had one. Only known bronchiectasis with a previous CT scan should be excluded).
•Antibiotics within the past 28 days, apart from oral macrolides which are permitted if they have been used for at least 3 months prior to randomization
•Oral/ nasal corticosteroids of any kind in the 28 days prior to screening visit
•Current use of the following: roflumilast, ritonavir, itraconazole, telithromycin, or ketoconazole (or other strong CYP3A4 inhibitors).
•Active, or within 28 days of screening visit, oral candidiasis, actively receiving dental treatment for oral infection or poor dentition.
•Immunosuppression including current oral corticosteroids at a dose >5mg for >28 days.
•Glomerular filtration rate (eGFR) below 30ml/min/1.73m2 or requiring dialysis. Last known eGFR result will be used .
•Use of any investigational drugs within five times of the elimination half-life after the last study dose or within 30 days, whichever is longer.
•Known allergy, intolerance or contraindication to any of the study drugs
•Galactose intolerance
•Unstable co-morbidities (cardiovascular disease, active malignancy) which in the opinion of the Investigator would make the patient unsuitable to be enrolled in the study. This includes any abnormality identified on screening bloods or screening ECG which in the opinion of the Investigator would make the patient unsuitable for the study.
•An exacerbation of COPD occurring during the screening to randomisation period. If this occurs the patient should be withdrawn from the study and may be rescreened once they have been free from corticosteroid and antibiotic treatment for 28 days. In these cases patients would receive the current Participant Information Sheet and be consented prior to starting the study from Visit 1.
•Documented that the patient has never received pneumococcal polysaccharide vaccination*
•Receipt of Pneumococcal conjugate vaccine (e.g PCV-13)*
•Pregnancy or breast feeding
•Women of child bearing potential (WOCBP) who are not practicing an acceptable method of contraception (see below)
Acceptable forms of contraception:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
• intrauterine device (IUD)
• intrauterine hormone-releasing system ( IUS)
• bilateral tubal occlusion
• vasectomised partner
• sexual abstinence

Study & Design

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