Status:
UNKNOWN
A System to Classify Treatable Traits in Primary Care
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Respiratory Disease
Asthma
Eligibility:
All Genders
18+ years
Brief Summary
This study proposes an approach to address an urgent unmet need in clinical practice, namely a pragmatic method of establishing what is the cause of a patient's complaint and the next steps to address...
Detailed Description
In respiratory diseases, the presenting symptoms are often a combination of cough, dyspnoea and wheeze. These three symptoms can be present in a significant number of conditions, including airways dis...
Eligibility Criteria
Inclusion
- Capable of understanding and willing to give voluntary informed consent prior to any protocol specific procedures being performed.
- Patients aged over 18 years.
- Present with persisting respiratory symptoms that are suggestive of airways disease.
- Capable of understanding and complying with the requirements of the protocol, including ability to attend for all 3 required visits.
- Able and willing to take inhaled medication via an Ellipta. \[In the opinion of the investigator suitable for use of this inhaler.\]
- Willing to use an electronic spirometer \& peak flow meter.
- Currently prescribed Inhaled Corticosteroids (ICS) either alone or in combination with long acting beta agonists (ICS/LABA)
Exclusion
- Have an active laboratory confirmed diagnosis of Asthma or COPD (with change to treatment within the last 8 weeks).
- Known previous sensitivity to ICS and Beta Agonist.
- Known significant (in the opinion of the investigator) concurrent medical disease that might mean that the patient cannot complete the full study.
- Intercurrent respiratory tract infection requiring antibiotic treatment in the last week
- Acute exacerbation of symptoms in the last 14 days requiring oral corticosteroid treatment
- Currently on specific concurrent potent cytochrome P450 3A4 (CYP3A4) medications; ketoconazole and ritonavir.
- Pregnancy
- Have greater than a 20-Pack Year Smoking History
Key Trial Info
Start Date :
May 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05357274
Start Date
May 16 2022
End Date
December 31 2024
Last Update
May 2 2022
Active Locations (1)
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1
Beaumont Hospital
Dublin, Ireland