se of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study.

Phase 1

• Conditions: Cystic fibrosis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-003501-10-SE
• Lead Sponsor: Västra Götalandsregionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

For inclusion in the study, subjects must fulfil the following criteria:
1.Signed informed consent form to participate in the trial, from both patient and its legal guardians according to national regulations
2.Diagnosis of Cystic Fibrosis
3.Age 3.0 to 17.9 years
4.MBW performed in the last 3 days with a relative increase in LCI =10% compared to former LCI
5.Two MBW performed in stable condition before inclusion in the last year, both being <11.0 and relative difference less than 10% between each other 6MBW must be performed without sedation and fulfil pre-established quality criteria

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects must not enter the study if any of the following criteria are fulfilled:
1. P. aeruginosa, A xyloxidans, B cepacia, NTM detected in sputum at inclusion
2. Chronic infection with P. aeruginosa,,A xyloxidans, B cepacia or NTM
3. Treated Acute Broncho pulmonary Aspergillosis at inclusion or in the last 12 months
4. Started CFTR-modulator < 4 weeks before inclusion
5. Change of inhalation therapy within last month (rhDNAse or hypertonic saline)
6. Ongoing treatment with antibiotics or treated with antibiotics in the last 21 days (only group A)
7. Started antibiotic treatment more than 5 days of before inclusion (=1st LCI) (only group B).
8. Other contraindication according to responsible physician at respective CF center
9. Being part in another CF trial
10. Previous lung transplantation
11. Pregnancy during the pre-screening period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified