Investigating whether two different COPD inhalers have different effects on chest infections

Phase 1

• Conditions: Chronic obstructive pulmonary disease; MedDRA version: 20.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000015472; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-004473-41-GB
• Lead Sponsor: niversity of Dundee and NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-11
• Study Completion: 2019-11-26
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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
•Post-bronchodilator FEV1/FVC ratio at screening of <70%
•Moderate to Very Severe COPD (GOLD II-IV) according to consensus guidelines consisting of a post-bronchodilator FEV1 <80% predicted at screening.
•Currently treated with inhaled corticosteroids (with or without long acting bronchodilators) for at least 12 months prior to screening.
•Able to perform all study procedures including spirometry and questionnaires with minimal assistance
•Blood eosinophil count less than 300 eosinophil cells per microlitre on bloods taken at screening.
•Able to produce a sputum sample at the baseline visit (nebulised sputum induction is acceptable)

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Inability to give informed consent
•Asthma
•Acute Antibiotics within 28 days prior to screening
•Current use of the following: roflumilast, ritonavir, itraconazole, telithromycin, or ketoconazole (or other strong CYP3A4 inhibitors).
•Systemic Immunosuppressive medication including current oral corticosteroids at a dose >5mg for >28 days.
•Glomerular filtration rate (eGFR) below 30ml/min/1.73m2 or requiring dialysis. This will be determined at screening.
•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
•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
•An exacerbation of COPD occurring during the 28 days prior to screening requiring treatment with either oral corticosteroids and antibiotics.
•An exacerbation requiring treatment with antibiotics or corticosteroids between the screening and randomization visit
•Pregnancy or breast feeding
•Women of child bearing potential (WOCBP) who are not practicing an acceptable method of contraception (see below)
•Long term oxygen therapy
•Lapp lactase deficiency, glucose-galactose malabsorption or another inherited disorder of galactose metabolism.
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