A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001888-21-GB

Enrollment

Registered

2005-02-22

Start date

2004-12-03

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fibrosis (CF)

Interventions

Product Name: DP Mannitol Pharmaceutical Form: Inhalation powder INN or Proposed INN: Mannitol Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of cystic fibrosis (sweat test or genotype) 2. Aged between 5 and 18 years 3. Have Forced Expiratory Volume in one second (FEV1) =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. 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. Subjects with currently active asthma 3. Colonised with Burkholderia cepacia 4. Considered “terminally ill” or listed for transplantation 5. Concurrent illnesses - Cor pulmonale, portal hypertension, varices 6. Requiring home oxygen or assisted ventilation 7. Significant episode of hemoptysis (>60 mL) in the previous 12 months 8. Heart attack or stroke in last 3 months 9. Known aortic aneurysm 10. Subjects who are breast feeding or pregnant. 11. At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study 12. Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry. 13. Known intolerance to mannitol, rhDNase or ß agonists. 14. Uncontrolled hypertension, systolic BP > 200, or diastolic BP> than 100

Design outcomes

Primary

Measure	Time frame
Main Objective: - To compare and contrast the effect on Forced Expiratory Volume in one second(FEV1) using a 12 week treatment regimen of: 1) mannitol to rhDNase, and 2) mannitol + rhDNase to rhDNase ; Secondary Objective: - To compare mannitol to rhDNase on Forced Vital Capacity (FVC) - To demonstrate that the effects of mannitol are additive to rhDNase - To demonstrate that mannitol does not cause deterioration in bronchial hyper-reactvity (BHR) or airway inflammation - To demonstrate that mannitol does not increase the bacterial load in the lung - To demonstrate that the effects of mannitol are beneficial to quality of life - To demonstrate that mannitol is a cost effective alternative to rhDNase ;Primary end point(s): Forced Expiratory Volume in one second (FEV1)	—

Measure

Time frame

Main Objective: - To compare and contrast the effect on Forced Expiratory Volume in one second(FEV1) using a 12 week treatment regimen of: 1) mannitol to rhDNase, and 2) mannitol + rhDNase to rhDNase ; Secondary Objective: - To compare mannitol to rhDNase on Forced Vital Capacity (FVC) - To demonstrate that the effects of mannitol are additive to rhDNase - To demonstrate that mannitol does not cause deterioration in bronchial hyper-reactvity (BHR) or airway inflammation - To demonstrate that mannitol does not increase the bacterial load in the lung - To demonstrate that the effects of mannitol are beneficial to quality of life - To demonstrate that mannitol is a cost effective alternative to rhDNase ;Primary end point(s): Forced Expiratory Volume in one second (FEV1)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026