Clinical Trials Register

Summary
EudraCT Number:	2021-002335-33
Sponsor's Protocol Code Number:	KKS287
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-11-19
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2021-002335-33

A.3

Full title of the trial

Inhaled ColiFin® in adult bronchiectasis patients with new asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial

Inhaliertes ColiFin® in erwachsenen Bronchiektasie Patienten mit neuer asymtomatischer Pseudomonas aeruginosa Infektion- eine unverblindete, randomisierte Proof of Concept IIT Studie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Inhalation therapy in adult bronchiectasis patients with new asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial

Inhalationstherapie bei erwachsenen Bronchiektase-Patienten mit neuer asymptomatischer Pseudomonas aeruginosa-Infektion - eine offene, randomisierte Proof of Concept IIT Studie

A.3.2

Name or abbreviated title of the trial where available

ERADICATE

A.4.1

Sponsor's protocol code number

KKS287

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Philipps University Marburg
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	German Center for Lung Research (DZL)
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	PARI GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Koordinierungszentrum für Klinische Studien (KKS) Marburg
B.5.2	Functional name of contact point	KKS Marburg
B.5.3	Address:
B.5.3.1	Street Address	Karl-von-Frisch-Straße 4
B.5.3.2	Town/ city	Marburg
B.5.3.3	Post code	35043
B.5.3.4	Country	Germany
B.5.6	E-mail	constanze.maresch@kks.uni-marburg.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ColiFin(R)
D.2.1.1.2	Name of the Marketing Authorisation holder	PARI Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ColiFin
D.3.2	Product code	J01X B01
D.3.4	Pharmaceutical form	Powder and solvent for nebuliser solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

bronchiectasis

E.1.1.1

Medical condition in easily understood language

permanent enlargement of parts of the airways of the lung (bronchiectasis), with inflammatory processes

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10006445
E.1.2	Term	Bronchiectasis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the effect of ColiFin® therapy for 4 weeks compared to no therapy on sputum/airway culture negativity for PA 28 weeks after randomisation

E.2.2

Secondary objectives of the trial

• To evaluate the effect of ColiFin® therapy for 4 weeks compared to no treatment on
change in PA bacterial density (colony forming units; CFUs) in sputum from baseline to Day 29 of treatment
the frequency of (mild to moderate) pulmonary exacerbations (requiring antibiotic treatment) in 28 weeks after Randomisation
the frequency of severe exacerbations (hospitalizations) in 28 weeks after Randomisation
time to first pulmonary exacerbation (requiring antibiotic treatment) after start of treatment
quality of life (QoL) measured by the St. George’s Respiatory Quenstionnaire (SGRQ)
Respiratory Symptom Score (RSS) measured by the Quality of Life Questionnaire Bronchiectasis (QoL-B)
overall QoL measured by the Quality of Life Questionnaire Bronchiectasis (QoL-B)
• To evaluate the effect of ColiFin® therapy for 4 weeks compared to no treatment on change in ppFEV1
• To evaluate the change in antibiotic susceptibility in sputum bacteria over the 24 weeks follow up period

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age ≥ 18 years at screening.
2. Bronchiectasis verified by chest CT scan.
3. New positive sputum culture for PA (not older than 12 weeks at screening).

4. No recent onset of new respiratory symptoms or worsening of pre-existing respiratory symptoms (e.g. cough, sputum amount, sputum colour, sputum viscosity, haemoptysis, decreased exercise capacity, malaise, fatigue etc.) over the last 2 months before new positive PA sputum culture, as per investigator judgement.
5. Written informed consent.
6. Negative serum/urine pregnancy test in women of childbearing potential (WOCBP) at screening,
7. WOCBP must agree to maintain a highly effective method of contraception during study treatment and at least 4 weeks thereafter.

Such methods include:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
• intrauterine device (IUD)
• intrauterine hormone-releasing system (IUS)
• bilateral tubal occlusion
• vasectomised partner
• sexual abstinence

8. Male subjects have to use condom during treatment and until the end of relevant systemic exposure in the male subject, plus a further 90-day period and non-pregnant WOCBP partner have to use any contraception method additionally.

E.4

Principal exclusion criteria

1. Bronchiectasis due to cystic fibrosis
2. Known prior infection with PA in the past 5 years before the new positive PA culture*
3. Treatment with pseudomonas-active antibiotics in the period between new PA positive sputum culture and baseline visit.
4. Planned pseudomonas-active antibiotic treatment during the time of study participation.
5. Any treatment with inhaled antibiotics or long-term pseudomonas-active treatment (≥3 months) in the past 5 years before screening.
6. Known intolerance to ColiFin® in prior medical history.
7. Hypersensitivity/Known intolerance to Colistimethate sodium, Colistin, polymyxin B or to other polymyxins.
8. Known diagnosis of myasthenia gravis or porphyria
9. ppFEV1 < 30% (post-bronchodilator)
10. Pregnant women
11. Breast feeding women
12. strongly impaired renal function, GFR ≤ 30 ml/min
13. Participation in any other interventional clinical trial

*Patients with a positive culture for PA from respiratory specimens within the past 5 years, but within a time frame of ≥3 years before new PA detection, who had at least 2 negative cultures for PA from respiratory specimens per year within these 3 years while not on pseudomonas-active treatment are also regarded as PA negative and can be included in the trial. Respiratory specimens include throat swab, sputum, tracheal/bronchial secretion and bronchial lavage fluid

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the proportion of sputum/airway culture negativity (=3 consecutively negative sputum/airway cultures) for PA 28 weeks after randomisation

E.5.1.1

Timepoint(s) of evaluation of this end point

28 weeks after randomisation

E.5.2

Secondary end point(s)

• Change in PA colony forming units (CFUs) in sputum from baseline to Day 29 of treatment
• Rate of pulmonary exacerbations in 28 weeks after randomisation
• Rate of severe exacerbations (hospitalizations) in 28 weeks after randomisation
• Time to first pulmonary exacerbation after start of treatment
• Change from baseline in respiratory symptom domain of the SGRQ over the 24 weeks follow up period
• Change from baseline in quality of life measured by SGRQ over the 24 weeks follow up period
• Change from baseline in quality of life measured by QOL-B over the 24 weeks follow up period
• Change from baseline on change in ppFEV1 over the 24 weeks follow up period
• Change in antibiotic susceptibility in isolated sputum PA over the 24 weeks follow up period

E.5.2.1

Timepoint(s) of evaluation of this end point

28 weeks after randomisation

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

comparison to control group (standard of care)

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS + database closure

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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)

Information not present in EudraCT

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Best medical care according to guidelines will be given to all patients.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-03-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-05-18

P. End of Trial
P.	End of Trial Status	Ongoing

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