NCT02134353.
| Study name | Long‐Term Administration of Inhaled Mannitol in Cystic Fibrosis ‐ A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects |
| Methods | Randomised, double‐blind, parallel study. Treatment duration: 26 weeks. Multicentre in USA, Argentina, Australia, Belgium, Canada, Czech Republic, Hungary, Israel, Italy, Mexico, New Zealand, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine. |
| Participants | Estimated enrolment: 440 adults with CF (18 years or older). |
| Interventions | Inhaled mannitol 400 mg twice daily versus inhaled control twice daily for 26 weeks. |
| Outcomes | Primary outcome: FEV1 (mean absolute change in mL) over weeks 6, 14 and 26 with a REML‐based repeated measures approach. Secondary outcomes: FVC (mean change from baseline in mL); time to first pulmonary exacerbation; rate of pulmonary exacerbations; number of days in hospital due to pulmonary exacerbation; incidence of pulmonary exacerbations; days on antibiotics (oral, inhaled or IV) due to pulmonary exacerbation; ease of expectoration measured using a visual analogue scale; CFQ‐R respiratory domain score. |
| Starting date | October 2014. |
| Contact information | April 2016 (March 2016 is final data collection date for primary outcome measure). |
| Notes | Contact: Brett Charlton (brett.charlton@pharmaxis.com.au). |
CF: cystic fibrosis CFQ‐R: cystic fibrosis questionnaire (revised) FEV1: forced expiratory volume at one second FVC: forced vital capacity IV: intravenous REML: restricted maximum likelihood