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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	26 October 2021
Main ID:	EUCTR2013-004295-35-AT
Date of registration:	02/04/2014
Prospective Registration:	Yes
Primary sponsor:	Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)
Public title:	Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study
Scientific title:	Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT
Date of first enrolment:	30/04/2014
Target sample size:	15
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004295-35
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
Austria

Contacts

Name:	Clinical Trial Center
Address:	Anichstraße 35 6020 Innsbruck Austria
Telephone:
Email:	ctc@i-med.ac.at
Affiliation:	Medical University Innsbruck

Name:	Clinical Trial Center
Address:	Anichstraße 35 6020 Innsbruck Austria
Telephone:
Email:	ctc@i-med.ac.at
Affiliation:	Medical University Innsbruck

Key inclusion & exclusion criteria

Inclusion criteria:
- patients suffering from cystic fibrosis
- age >= 12 years
- chronic P. aeruginosa lung infection
- clinically stable at outpatient visit
- FEV1 >= 75 % of predicted previous antibiotic aerosol treatment
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- patients with CF related liver disease or renal disease
- pregnant and nursing women

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic lung P. Aeruginosa Infection
MedDRA version: 16.1 Level: PT Classification code 10061229 Term: Lung infection System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
Pharmaceutical Form: Powder and solvent for nebuliser solution
INN or Proposed INN: aztreonam
CAS Number: 827611-49-4
Other descriptive name: AZTREONAM LYSINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-75

Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
Pharmaceutical Form: Powder and solvent for nebuliser solution
INN or Proposed INN: COLISTIMETHATE SODIUM
CAS Number: 8068-28-8
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1.000.000-1.000.000

Trade Name: TOBI
300 mg/5 ml - Lösung für einen Vernebler
Product Name: Tobi
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: TOBRAMYCIN SULFATE
CAS Number: 79645-27-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-300

Primary Outcome(s)

Main Objective: To compare the changes in lung clearance index before and after each 4-week-on/4-week-off cycle of different inhaled antibiotics

Timepoint(s) of evaluation of this end point: at week 0, 4, 8 and 12

Primary end point(s): relative change in LCI after treatment with AZLI and after standard therapy

Secondary Objective: not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: not applicable

Secondary end point(s): not applicable

Secondary ID(s)

LCI-OUT

Source(s) of Monetary Support

Gilead Sciences

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 24/10/2013
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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