Clinical Trials Register

Summary
EudraCT Number:	2014-000844-13
Sponsor's Protocol Code Number:	SMR-2984
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-07-21
Trial results	View 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

Sweden - MPA

A.2

EudraCT number

2014-000844-13

A.3

Full title of the trial

A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis.

A.3.1

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

A phase IIb study of OligoG in subjects with cystic fibrosis

A.3.2

Name or abbreviated title of the trial where available

A phase IIb study of OligoG in subjects with cystic fibrosis

A.4.1

Sponsor's protocol code number

SMR-2984

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	Algipharma AS
B.1.3.4	Country	Norway
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Eurostars
B.4.2	Country	European Union
B.4.1	Name of organisation providing support	Algipharma AS
B.4.2	Country	Norway
B.4.1	Name of organisation providing support	Smerud Medical Research
B.4.2	Country	Norway
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SMERUD Medical Research
B.5.2	Functional name of contact point	Project Manager
B.5.3	Address:
B.5.3.1	Street Address	Drammensveien 41
B.5.3.2	Town/ city	Oslo
B.5.3.3	Post code	N-0271
B.5.3.4	Country	Norway
B.5.4	Telephone number	472327 2000
B.5.5	Fax number	472327 2001
B.5.6	E-mail	jacobo.blanco@smerud.com

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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/07/475
D.3 Description of the IMP
D.3.1	Product name	OligoG CF-5/20
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Oligomer of Sodium Alginate
D.3.9.2	Current sponsor code	OligoG
D.3.9.3	Other descriptive name	OLIGOG CF-5/20
D.3.9.4	EV Substance Code	SUB130807
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	35
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	No
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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Inhalation powder, hard capsule
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Cystic Fibrosis

E.1.1.1

Medical condition in easily understood language

Cystic Fibrosis

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demonstrate efficacy of inhaled OligoG measured by FEV-1 and supported by secondary endpoints including Mucociliary Clearance, rheology, microbiology and Quality-of-Life

E.2.2

Secondary objectives of the trial

To demonstrate the safety and tolerability of inhaled OligoG as a dry powder for inhalation after multiple dose administration.

To evaluate patient compliance with treatment.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Male or female with a confirmed diagnosis of cystic fibrosis defined by:
a. Clinical features consistent with the diagnosis of CF [(Rosenstein BJ and Cutting GR 1998)]; AND Sweat chloride ≥60 mmol/L by pilocarpine iontophoresis;
OR
b. Genotypic confirmation of CFTR mutation
2) Aged 18 years or older
3) Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or cough swab documented within 24 months prior to Screening (Visit 1).
4) FEV1 must, at Screening (Visit 1), be between 40%-100% of the predicted normal value following adjustment for age, gender, and height according to the Global Lung Initiative (GLI) equation (Eur Respir J. Dec 2012; 40(6): 1324–1343). See Section 12.10 for a GLI calculator. For subjects to be included in the LCI assessment at selected sites, the FEV1 at screening should be in the range of 60-100%.
5) At Screening (Visit 1), no clinical or laboratory findings suggestive of significant pulmonary illness, other than CF, which in the opinion of the investigator would preclude participation in the study
6) Female subjects of child bearing potential and male subjects participating in the study who are sexually active must use acceptable contraception. Female subjects documented as being of non child-bearing potential (Section 4.2.9) are exempt from the contraceptive requirements. For the purpose of this study acceptable contraception is defined as:
a. oral, injected transdermal or implanted hormonal methods of contraception; OR
b. placement of an intrauterine device (IUD) or intrauterine system (IUS); OR
c. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
7) Provision written informed consent

E.4

Principal exclusion criteria

1) Changes in underlying therapy (e.g., chest physiotherapy, bronchodilators, NSAIDs, antibiotic agents, pancreatic enzyme preparations, nutritional supplements and DNase within the 14 days prior to Day 0 (Visit 2). Subjects must be willing to remain on the same underlying stable therapy regimens for the duration of the study until the final follow-up visit at Day 98.
2) Changes in physiotherapy technique or schedule within 14 days prior to Day 0 (Visit 2).
3) Prohibited medications within 7 days prior to Day 0 (Visit 2). Prohibited medications are described in Section 5.6.
4) Pulmonary exacerbation within 28 days of Screening (Visit 1)
5) Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough swab documented within 12 months prior to Screening (Visit 1).
6) Lactose intolerance/milk allergy. A skin test for milk allergy will be performed for lactose intolerance unknowns at screening. Subjects that have previously received inhaled formulations containing lactose without any allergic or tolerance issues are allowed to proceed without a skin test. For subjects demonstrating a positive skin prick test for milk allergy but have no problems with eating milk and lactose products, the decision will be up to the investigator’s discretion.
7) On-going acute illness. Subjects must not have needed an outpatient visit, hospitalization or required any change in therapy for other pulmonary disease between Screening (Visit 1) and Day 0 (Visit 2).
8) History of, or planned organ transplantation.
9) Allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to Screening (Visit 1), defined as having received treatment for ABPA.
10) Requirement for continuous (24 hour/day) oxygen supplementation.
11) Diagnosed with the G551D-mutation, and currently on concomitant treatment with Ivacaftor (Kalydeco).
12) Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 0 (Visit 2). Subjects on hypertonic saline can if needed switch to isotonic saline 7 days prior to Day 0.
13) Initiation of cycled, inhaled tobramycin (TOBI) and Colistin less than 4 months prior to Screening (Visit 1). Note: Chronic TOBI and Colistin users are allowed to participate in this study, but subjects who have recently initiated chronic TOBI or Colistin should have at least 2 cycles of TOBI or Colistin respectively in the preceding 4 months before being enrolled in this study. Chronic TOBI and Colistin subjects should be starting an ‘off-TOBI’ or alternatively ‘off-Colistin’ period at Day 0 (Visit 2), to make sure that the treatment is phased in line with the antibiotic treatment.
14) Concomitant use of all other marketed antibiotic agents is permitted, providing subjects are willing to remain on the same regimens within the 21 days immediately prior to Day 0 (Visit 2) and for the entire duration of the study (until Day 98).
15) Clinically significant abnormal findings on haematology or clinical chemistry. In addition any value ≥ 3 x the upper limit of normal will exclude the subject from participating in the study.
16) Subjects unable to perform pulmonary function tests according to the ATS/ERS criteria.
17) Pregnant or breast-feeding women. A negative urine pregnancy test must be demonstrated in females of child-bearing potential (Section 4.2.9) at Screening (Visit 1).
18) Subjects who have participated in any interventional clinical trial within the 28 days prior to Day 0 (Visit 2).
19) Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the Investigator.
20) Current malignant disease (with the exception of basal cell carcinoma and cervical neoplasia).
21) Any serious or active medical or psychiatric illness, which in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
22) DPI intolerance, active or placebo.
For MCC sites only:
23) Smoking. A negative Cotinine test must be demonstrated at Screening (Visit 1)
24) Subjects who have any non-removable metal objects such as metal plates, screws etc in their head, neck, chest or abdominal area except for Port-a-Cath®s or other implantable ports.

E.5 End points

E.5.1

Primary end point(s)

FEV1

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline and day 28 of each treatment period

E.5.2

Secondary end point(s)

1) Combined mucociliary and cough clearance at selected sites (no sites in Sweden)
2) Quality of Life by CFQ-R
3) Sputum rheology
4) Microbiological (culture and culture independent) measurements including P. aeruginosa density in expectorated sputum
5) Other lung function tests

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline and day 28 of each treatment period

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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Yes

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

Last visit of last subject

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

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)

Yes

F.1.3.1

Number of subjects for this age range:

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

None

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

2014-09-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-07-19

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