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A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis (SMR-2984)

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ClinicalTrials.gov Identifier: NCT02157922
Recruitment Status : Active, not recruiting
First Posted : June 6, 2014
Last Update Posted : January 27, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: alginate oligosaccharide Phase 2

Detailed Description:

The primary objective is to demonstrate efficacy of inhaled OligoG measured by FEV1, and supported by secondary endpoints including Mucociliary Clearance, rheology,microbiology and Quality-of-Life.

The secondary objectives are

  1. To demonstrate the safety and tolerability of inhaled OligoG as a dry powder for inhalation after multiple dose administration; and
  2. To evaluate patient compliance with treatment.

The design will be randomized, double-blind, placebo-controlled, multi-center, cross-over phase II study. Mucociliary and Cough clearance (MCC) will be an exploratory endpoint in a subset of 24 patients, and Lung Clearance Index (LCI) an exploratory endpoint in another subset of 20 or more patients.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis
Study Start Date : October 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Alginate oligosaccharide
Inhalation of a dry powder OligoG in the first treatment period, and of placebo the second period
Drug: alginate oligosaccharide
Inhalation
Other Name: OligoG
Placebo Comparator: Placebo
Inhalation of placebo dry powder in the first treatment period, and OligoG in the second period
Drug: alginate oligosaccharide
Inhalation
Other Name: OligoG


Outcome Measures

Primary Outcome Measures :
  1. FEV1 (Forced Expiratory Volume in 1 second) [ Time Frame: 28 days, i.e. start and end of treatment periods ]
    An improvement in FEV1 during treatment with OligoG as compared to placebo is the primary endpoint of the study.


Secondary Outcome Measures :
  1. Mucociliary and cough clearance [ Time Frame: 28 days, i.e. start and end of treatment periods ]
    Mucociliary clearance is assessed by measuring the movement of an inhaled radiotracer up the airways.


Other Outcome Measures:
  1. Safety [ Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up ]
    Measurement of vital signs, ECG, blood oxygen saturation and pulmonary function tests. Adverse events and concomitant medications will be recorded, and blood samples will be collected for hematology, clinical chemistry and OligoG concentration.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female with a confirmed diagnosis of cystic fibrosis defined by:

    1. Clinical features consistent with the diagnosis of CF AND Sweat chloride ≥60 mmol/L by pilocarpine iontophoresis; OR
    2. Genotypic confirmation of CFTR mutation
  • Aged 18 years or older
  • Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or cough swab within 24 months prior to Screening
  • FEV1 between 40%-100%
  • At Screening no clinical or laboratory findings suggestive of significant pulmonary illness, other than CF
  • Female subjects of child bearing potential and sexually active male subjects must use contraception
  • Provision written informed consent

Exclusion Criteria:

  • Changes in underlying therapy within the 14 days prior to Day 0. 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.
  • Changes in physiotherapy technique or schedule within 14 days prior to Day 0.
  • Prohibited medications within 7 days prior to Day 0.
  • Pulmonary exacerbation within 28 days of Screening.
  • Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough swab documented within 12 months prior to Screening.
  • Lactose intolerance/milk allergy.
  • 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 and Day 0.
  • History of, or planned organ transplantation.
  • Treatment for Allergic bronchopulmonary aspergillosis (ABPA).
  • Requirement for continuous (24 hour/day) oxygen supplementation.
  • Diagnosed with the G551D-mutation, and currently on concomitant treatment with Ivacaftor (Kalydeco).
  • Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 0 (Visit 2).
  • 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. Treatment should be phased in line with the antibiotic treatment.
  • Concomitant use of all other marketed antibiotic agents is permitted, providing subjects are willing to remain on the same regimens within the 28 days immediately prior to Day 0 and for the entire duration of the study (until the follow-up visit).
  • 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.
  • Subjects unable to perform pulmonary function tests according to the ATS/ERS criteria.
  • 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.
  • Subjects who have participated in any interventional clinical trial within the 28 days prior to Day 0 (Visit 2).
  • Subjects with documented or suspected, clinically significant, alcohol or drug abuse.
  • Current malignant disease (with the exception of basal cell carcinoma and cervical neoplasia).
  • 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.
  • DPI intolerance, active or placebo

For MCC sites only:

  • Smoking. A negative Cotinine test must be demonstrated at Screening
  • Subjects who have any non-removable metal objects such as metal plates, screws etc in their head, neck, chest or abdominal area
  • Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 mSv), or will exceed 10 mSv over any three year period.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157922


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Germany
Pediatric Pulmonology and Immunology, Charité Universitätsmedizin
Berlin, Germany, 13353
CF Zentrum Köln, Universitätskrankenhaus Köln
Cologne, Germany, 50924
Medizinische Klinik I, Pneumologie, Uniklinik
Frankfurt, Germany, 60590
Klinik für Pneumologie, CF-Ambulanz
Hannover, Germany, 30625
Mukoviszidose-Zentrum für Erwachsene, Med. Klinik V-Innenstadt (LMU)
Münich, Germany, 80336
Pneumologische Praxis Pasing
Münich, Germany, 81241
Center for Pediatric Clinical Studies,
Tübingen, Germany, 72076
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sweden
CF-mottagningen, Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, 41345
Stockholm CF-center, Karolinska Universitetssjukhuset
Stockholm, Sweden, 14186
United Kingdom
Regional Respiratory Centre, Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Bio-Images Research Ltd, Basement Medical Block, Within GRI
Glasgow, United Kingdom, G4 0SF
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom, L14 3PE
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom, SW3 6NP
Queens Medical Centre
Nottingham, United Kingdom, NG7 2UH
Papworth Hospital
Papworth, United Kingdom, CB23 3RE
Southampton General Hospital
Southampton, United Kingdom
Sponsors and Collaborators
AlgiPharma AS
Eurostars
Smerud Medical Research International AS
Investigators
Principal Investigator: Tacjana Pressler, PhD MD Rigshospitalet, Denmark
More Information

Responsible Party: AlgiPharma AS
ClinicalTrials.gov Identifier: NCT02157922     History of Changes
Other Study ID Numbers: SMR-2984
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by AlgiPharma AS:
Cystic fibrosis
mucolytic
mucociliary clearance
lung clearance

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Alginic acid
Hemostatics
Coagulants
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs