Relief of breathlessness in heart failure patients by inhaling furosemide which is normally taken as a tablet or injection.

Phase 1

• Conditions: Advance heart failure - New York Class Association III-IV with ejection fraction <35%.; MedDRA version: 18.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2015-001468-21-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1)Patient is willing and able to give informed consent for participation in the trial.
2)Male or Female, aged 18 years or above. (There is no upper age limit although it will be at the discretion of the investigator to ensure they have the capacity to understand, consent and have the ability to perform the studies required).
3)Diagnosed with NYHA stage III or IV heart failure
4)Treated with oral furosemide for at least 3 weeks
5)Ambulatory and clinically stable in the previous 3 months
6)Documented left ventricular ejection fraction (LVEF) of <35%.

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 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1)Those unable to consent for themselves
2)History of allergic reaction (hypersensitive) to furosemide and/or any of the other ingredients of furosemide or amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co-trimoxazole
3)Individuals who are dehydrated or have significant symptomatic postural hypotension
4)Significant renal impairment (eGFR <15) or anuric
5)Significant hepatic impairment/cirrhosis (Child-Pugh class C)
6)Addison's disease
7)Digitalis intoxication
8)Porphyria
9)Individuals who are immunocompromised
10)Patient with life expectancy <6 months
11)Patients who are inappropriate for saline
12)Co-existent history of significant chronic obstructive pulmonary disease or asthma or interstitial lung disease or nasal polyps
13)Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient’s ability to participate in the trial.
14)Have participated in another research trial involving investigational product in the past 4 weeks.
15)Patients who have had an admission to hospital with heart failure within the last 3 months
16)Female patients who are pregnant, lactating or planning pregnancy over the course of trial.

Study & Design

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