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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 340

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

Exclusion Criteria

Subjects are excluded from participating in this study if one or more of the following criteria are met. The subject must NOT:
1. Be investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
2. Be considered terminally ill” or listed for lung transplantation
3. Have had a lung transplant
4. Be using nebulised hypertonic saline concurrently or in the 2 weeks prior to visit 1
5. Have had a significant episode of haemoptysis (>60 mL) in the three months prior to enrolment
6. Have had a myocardial infarction in the three months prior to enrolment
7. Have had a cerebral vascular accident in the three months prior to enrolment
8. Have had major ocular surgery in the three months prior to enrolment
9. Have had major abdominal, chest or brain surgery in the three months prior to enrolment
10. Have a known cerebral, aortic or abdominal aneurysm
11. Be breast feeding or pregnant, or plan to become pregnant while in the study
12. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
13. Be participating in another investigative drug study, parallel to, or within 4 weeks of study entry
14. Have a known allergy to mannitol
15. Be using beta blockers
16. Have uncontrolled hypertension – systolic BP > 190 and or diastolic BP > 100
17. Have a condition or be in a situation which in the Investigator’s opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient’s participation in the study
18. Be ‘Aridol-MTT test positive’.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of IDPM compared to control on FEV1 in patients with CF;Secondary Objective: • To determine the effect of IDPM compared to control on FEV1 in patients with CF on existing RhDNase treatment. (key objective)<br>To assess whether IDPM treatment:<br>• Reduces pulmonary exacerbations in those taking RhDNase as a sub-group and in the total cohort (key objective)<br>• Improves quality of life (key objective)<br>• Reduces days on IV antibiotics, rescue oral or inhaled antibiotics<br>• Reduces days in hospital due to pulmonary exacerbations<br>• Improves other measures of lung function <br>• Demonstrates an appropriate safety profile (adverse events, haematology, biochemistry, change in bronchodilator response, sputum microbiology, physical examination)<br>• Reduces hospital and community care costs ;Primary end point(s): Change in absolute FEV1 (forced expiratory volume in 1 second)

Secondary Outcome Measures

Name	Time	Method

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