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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003501-10-DK

Enrollment

100

Registered

2020-04-22

Start date

2021-01-22

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

Cystic fibrosis MedDRA version: 22.1 Level: LLT Classification code 10068288 Term: Cystic fibrosis pulmonary exacerbation System Organ Class: 100000004862

Interventions

Pharmaceutical Form: INN or Proposed INN: AMOXICILLIN CAS Number: 26787-78-0 Pharmaceutical Form: INN or Proposed INN: CLAVULANIC ACID CAS Number: 58001-44-8 INN or Proposed INN: AMOXICILLIN CAS Nu

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to show if an increase with =10% in LCI compared to former LCI can be reversed with oral antibiotic treatment (and without treatment LCI will remain high or increase). The hypothesis is that the increase in LCI = 10% is caused by an increased inflammation from bacterial colonization in the airways.;Secondary Objective: The secondary objective(s) of this study is to understand if: 1. If the length of treatment with antibiotics will affect LCI outcome 2. FEV1.0 changes over time when LCI increases with =10% compared to former LCI and if FEV1.0 are altered/affected by antibiotic treatment. 3. CFQ-R respiratory domain is changed after different treatment policies in group A and B Exploratory objective: Sn III analysis (measurement derived from MBW) is affected when LCI increases with =10% compared to former LCI and if they are altered/affected by antibiotic treatment. ;Primary end point(s): Lung Clearance Index (LCI);Timepoint(s) of evaluation of this end point: 4-6 weeks after inclusion	—

Measure

Time frame

Main Objective: The primary objective is to show if an increase with =10% in LCI compared to former LCI can be reversed with oral antibiotic treatment (and without treatment LCI will remain high or increase). The hypothesis is that the increase in LCI = 10% is caused by an increased inflammation from bacterial colonization in the airways.;Secondary Objective: The secondary objective(s) of this study is to understand if: 1. If the length of treatment with antibiotics will affect LCI outcome 2. FEV1.0 changes over time when LCI increases with =10% compared to former LCI and if FEV1.0 are altered/affected by antibiotic treatment. 3. CFQ-R respiratory domain is changed after different treatment policies in group A and B Exploratory objective: Sn III analysis (measurement derived from MBW) is affected when LCI increases with =10% compared to former LCI and if they are altered/affected by antibiotic treatment. ;Primary end point(s): Lung Clearance Index (LCI);Timepoint(s) of evaluation of this end point: 4-6 weeks after inclusion

—

Secondary

Measure	Time frame
Secondary end point(s): 1. FEV1, derived from spirometry 2. CFQ-R pulmonary part. 3. Explanatory: Sn III analysis derived from Multiple Breath Washout using nitrogen as an inert gas.;Timepoint(s) of evaluation of this end point: For all secondary endpoints: 4-6 weeks after inclusion	—

Countries

Denmark, Norway, Sweden

Contacts

Public ContactCF-mottagningen

Västra Götalandsregionen

marcus.svedberg@vgregion.se

Outcome results

None listed

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