None listed
Conditions
Brief summary
This is a research study to evaluate Citramel inhalation. The study is an open label administration of Citramel to 5 healthy volunteers to evaluate safety and tolerability.
Interventions
Citramel - an aqueous solution of sodium citrate (16.18 mg/mL), citric acid (0.046 mg/mL) and ammonium chloride (4.12 mg/mL). Administered by aerosol twice daily (morning and night) for 28 days. Compliance will be assessed by checking the vials returned by study participants.
Sponsors
Breathe Easy Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers aged 18-60 years who provide written informed consent; BMI 18-32 kg/m2; FEV1 between 80-120% of normal range; sexually active females must use contraception.
Exclusion criteria
Clinically significant co-existing disease; current or previously clinically significant smoking history; any medications (except oral contraceptives); ECG or blood pressure abnormalities; positive results on drugs of abuse or alcohol screen; greater than 15% improvement in FEV1 15 minutes post dose of bronchodilator at screening.
Outcome results
None listed