A clinical trial comparing the difference between participants who are frequently monitored for their compliance with their inhaler medication and participants who receive only their routine care in people suffering from asthma or COPD

Not Applicable

• Conditions: Chronic airway disease (Asthma or COPD); Respiratory

• Registration Number: ISRCTN14101933
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-21
• Last Update Posted: 19 August 2024
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

1. Clinically diagnosed airway disease (asthma or COPD)
2. Blood eosinophil count of = 0.2 x 109/L either at the clinic visit or any one time in the preceding 24 months
3. History of Exacerbation prone airway disease” (defined as 2 or more exacerbations requiring oral corticosteroids and or antibiotics within 12 months of initial pre-screening review)
4. Male and female patients aged 18 years and over
5. Willing and able to consent to participate in trial
6. Able to use a smartphone device and comply with biomarker guided protocol

Exclusion Criteria

1. Unable to give informed consent
2. Unable to use a smartphone device and or comply with biomarker guided protocol
3. Absence of eosinophilia (defined as persistently < 0.2 x 109 cells/L withing the last 24 months)
4. History of unstable or severe cardiac, hepatic, thyrotoxicosis, or renal disease, or other medically significant illness which the investigator believes would be a contraindication to study participation
5. Current or within the last 6 months (or maximum relevant wash out period, whichever is longer), participation in an investigational medicinal product (IMP) or device trial at the time of screening
6. History of long QT syndrome or whose QTcF interval (Fridericia’s) is prolonged >450 msec at screening or baseline
7. History of previous hospital admission as pneumoniaa (with radiological lung changes) prior to 12 months of study screening
8. History of human immunodeficiency virus (HIV) or hepatitis B or C
9. History of active Malignancy in any organ system (diagnosis within last 12 months or ongoing active cancer treatment such as chemotherapy, radiotherapy, or immunotherapy
10. Patients whose treatment is considered palliative (life expectancy < 6 months).
11. Pregnancy/lactating or intends to become pregnant during the study period where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test in urine or serum
12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, who are not able to use effective methods of contraception during dosing of trial treatment and for a minimum of 1 month after their last treatment
13. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening including (but not limited to):
13.1. AST or ALT >2.0x upper limit of normal (ULN)
13.2. Total bilirubin >1.3 X ULN at screening (except for patients with Gilberts syndrome where suitability for inclusion will be left to the discretion of the local investigator)

Study & Design

• Study Type: Interventional
• Study Design: Not specified