None listed
Conditions
Brief summary
This is a research study to evaluate Citramel inhalation. It is a double-blind, placebo, cross-over design to assess the safety, tolerability and efficacy of Citramel in approx. 24 cystic fibrosis patients.
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. This study is a randomised crossover design and there is a washout period of 14 days before the second study treatment is started.
For patients being treated with Tobramycin: this should be administered at least ten minutes after completion of the inhalation of study medication is inhaled. Note that the
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. This study is a randomised crossover design and there is a washout period of 14 days before the second study treatment is started. For patients being treated with Tobramycin: this should be administered at least ten minutes after completion of the inhalation of study medication is inhaled. Note that the nebulizing equipment provided for the study medications should NOT be used to administer tobramycin.
Sponsors
Breathe Easy Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Confirmed diagnosis of cystic fibrosis; aged at least 16 years who provide written informed consent; sexually active females must use contraception; stable medications; FEV1 between 40-100% of normal range.
Exclusion criteria
Clinically significant co-existing disease; current or previous clinically significant smoking history; ECG or blood pressure abnormalities; use of a bronchodilator within 12hrs prior to bronchodilator challenge at screening; renal impairment; elevated liver enzymes;
Outcome results
None listed