A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis

NCT02157922 | Completed Phase 2 DMC

• 1 other identifier: SMR-2984
• Study Type: interventional
• Target: 65
• Locations: 5 countries
• Sites: 18

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; mucolytic; mucociliary clearance; lung clearance

Outcome Measures

Primary Outcomes (1)

• FEV1 (Forced Expiratory Volume in 1 second)

  An improvement in FEV1 during treatment with OligoG as compared to placebo is the primary endpoint of the study.

  28 days, i.e. start and end of treatment periods

Secondary Outcomes (1)

• Mucociliary and cough clearance

  28 days, i.e. start and end of treatment periods

Other Outcomes (1)

• Safety

  Screening, day 0, 14, 28, 56, 70, 84 and follow up

Study Arms (2)

Alginate oligosaccharide

ACTIVE COMPARATOR

Inhalation of a dry powder OligoG in the first treatment period, and of placebo the second period

Drug: alginate oligosaccharide

Placebo

PLACEBO COMPARATOR

Inhalation of placebo dry powder in the first treatment period, and OligoG in the second period

Drug: alginate oligosaccharide

Interventions

alginate oligosaccharide DRUG

Inhalation

Also known as: OligoG

Alginate oligosaccharide; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with a confirmed diagnosis of cystic fibrosis defined by:
• Clinical features consistent with the diagnosis of CF AND Sweat chloride ≥60 mmol/L by pilocarpine iontophoresis; OR
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AlgiPharma AS: lead
• Eurostars: collaborator
• Smerud Medical Research International AS: collaborator

Study Sites (18)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Pediatric Pulmonology and Immunology, Charité Universitätsmedizin

Berlin, 13353, Germany

Location

CF Zentrum Köln, Universitätskrankenhaus Köln

Cologne, 50924, Germany

Location

Medizinische Klinik I, Pneumologie, Uniklinik

Frankfurt, 60590, Germany

Location

Klinik für Pneumologie, CF-Ambulanz

Hanover, 30625, Germany

Location

Mukoviszidose-Zentrum für Erwachsene, Med. Klinik V-Innenstadt (LMU)

Münich, 80336, Germany

Location

Pneumologische Praxis Pasing

Münich, 81241, Germany

Location

Center for Pediatric Clinical Studies,

Tübingen, 72076, Germany

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

CF-mottagningen, Sahlgrenska Universitetssjukhuset

Gothenburg, 41345, Sweden

Location

Stockholm CF-center, Karolinska Universitetssjukhuset

Stockholm, 14186, Sweden

Location

Regional Respiratory Centre, Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Papworth Hospital

Cambridge, CB23 3RE, United Kingdom

Location

Bio-Images Research Ltd, Basement Medical Block, Within GRI

Glasgow, G4 0SF, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

Royal Brompton and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Queens Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Related Publications (1)

• Hurley MN, Smith S, Forrester DL, Smyth AR. Antibiotic adjuvant therapy for pulmonary infection in cystic fibrosis. Cochrane Database Syst Rev. 2020 Jul 16;7(7):CD008037. doi: 10.1002/14651858.CD008037.pub4.

  PMID: 32671834 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

oligoG CF-5-20

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Tacjana Pressler, PhD MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 19, 2018

Record last verified: 2016-08

Locations

SE (2); GB (7); DE (7); NO (1); DK (1)