Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study

INTERVENTION: Product Name: IDPM: Inhaled Dry Powder Mannitol Product Code: IDPM Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: MANNITOL CAS Number: 69658 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use CONDITION: Cystic Fibrosis ; MedDRA version: 8.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis PRIMARY OUTCOME: Main Objective: To determine the effect of IDPM compared to control on FEV1 in patients with CF Primary end point(s): Change in absolute FEV1 (forced expiratory volume in 1 second) Secondary Objective: • To determine the effect of IDPM compared to control on FEV1 in patients with CF on existing RhDNase treatment. (key objective); To assess whether IDPM treatment:; • Reduces pulmonary exacerbations in those taking RhDNase as a sub‐group and in the total cohort (key objective); • Improves quality of life (key objective); • Reduces days on IV antibiotics, rescue oral or inhaled antibiotics; • Reduces days in hospital due to pulmonary exacerbations; • Improves other measures of lung function ; • Demonstrates an appropriate safety profile (adverse events, haematology, biochemistry, change in bronchodilator response, sputum microbiology, physical examination); • Reduces hospital and community care costs INCLUSION CRITERIA: Subjects may be included in the study if all of the following criteria are met. The subject must: 1. Have given written informed consent to participate in this study in accordance with local regulations 2. Have a confirmed diagnosis of cystic fibrosis 3. Be aged >= 6 years 4. Have FEV1 >=30 % and <90% predicted 5. Be able to perform all the techniques necessary to measure lung function Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range