Status:
TERMINATED
COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2
Lead Sponsor:
Thirty Respiratory Limited
Conditions:
COPD
Bronchiectasis
Eligibility:
All Genders
35+ years
Phase:
PHASE2
Brief Summary
Patients with a respiratory disease are at higher risk of poor outcomes due to worsening of symptoms caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and other respiratory infect...
Eligibility Criteria
Inclusion
- Female of non-childbearing potential or male ≥35 years of age, at the time of signing the informed consent
- Able and willing to provide informed consent
- Spirometry-confirmed diagnosis of COPD (FEV1/FVC\<0.7 post-bronchodilator) or computerised tomography (CT) proven bronchiectasis
- Part 1 only: FEV1 ≥50% predicted at screen 1 (i.e. FEV1 prior to any in-clinic administered short acting bronchodilator)
Exclusion
- Unable to safely use a nebuliser as required by the study according to Investigator's opinion
- Severe COPD or bronchiectasis defined as FEV1 \<20% or requiring non-invasive ventilation
- History of methaemoglobinaemia
- Baseline methaemoglobin concentration (using fingertip sensor) \> 2%
- Uncontrolled or severe asthma or history of severe bronchospasm
- Presence of tracheostomy/inability to provide spirometry or contraindication for performing spirometry
- Allergy to any of the components of the study intervention
- Participation in other clinical investigations utilising investigational treatment within the last 30 days / 5 half lives whichever is longer
- Deemed unlikely to be able to adhere to protocol in view of investigator
- Any subject who in the opinion of the investigator would not be best served by participating in this clinical trial
- Any unstable, uncontrolled or severe medical condition which in the opinion of the investigator would make the patient unsuitable for the trial
- Participant lives at home with no other adults in the household (Part 2 only)
- On long-term non-invasive ventilation and/or at higher risk of bronchospasm
- Prescribed Nitric Oxide donating agent (Nitroprusside, Isosorbide dinitrate, Isosorbide mononitrate, Naproxcinod, Molsidomine and Linsidomine)
- Female of childbearing potential
- Clinical diagnosis of COPD but Screening Visit spirometry at study centre excludes COPD (i.e. FEV1/FVC post bronchodilator ratio is not \<0.7)
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04858451
Start Date
March 1 2021
End Date
February 8 2023
Last Update
January 31 2025
Active Locations (2)
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1
Medicines Evaluation Unit
Manchester, United Kingdom
2
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom