Soulsby 2010.
| Methods | Randomised controlled trial. Randomisation order generation using the toss of a coin. No blinding. Open (masking not used). Phase IV trial. |
| Participants | Diagnosed with CF. Chronically colonised with P aeruginosa. Exacerbation of a lung infection. Male and female. Minimum age: 6 years old. Target sample size: 24. |
| Interventions | IV tobramycin at the dose they received on their last admission (usually 7 ‐ 10 mg/kg) once daily for 14 days versus inhaled tobramycin at a dose of 300 mg twice daily for 14 days. Cross‐over to other treatment arm at next admission (at least 6 weeks apart). |
| Outcomes |
Primary outcomes 1. FEV1 % predicted (measured at admission, on last day of treatment (day 14) and next clinical appointment ‐ usually 6 weeks after end of treatment). 2. Time to next admission for an exacerbation (measured in weeks). 3. Change in renal function (measured on day 1 and 8 using blood samples also measured using urine samples on day 1, 14 and at next clinic visit ‐ usually 6 weeks after end of treatment). Secondary outcomes 1. Weight measured (measured at admission, on last day of treatment (day 14) and next clinical appointment ‐ usually 6 weeks after end of treatment). 2. QoL questionnaire (measured at day 1 and 14). 3. Antibiotic resistance to P aeruginosa using sputum samples (day 1, 14 and next clinical appointment ‐ usually 6 weeks after end of treatment). |
| Notes | Funding source: The Society of Hospital Pharmacists of Australia, PO Box 1774, Collingwood, VIC 3066, Australia. We have no first‐arm data for this small cross over trial; author contacted to see if we can obtain the data we need to include it. |
FEV1: forced expiratory volume at 1 second FVC: forced vital capacity IV: intravenous P aeruginosa: Pseudomonas aeruginosa QoL: quality of life