Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02157922
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : April 19, 2018
Smerud Medical Research International AS
Information provided by (Responsible Party):
AlgiPharma AS

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 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
Actual Primary Completion Date : January 2017
Actual Study Completion Date : September 2017

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
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
Other Name: OligoG

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT02157922

Show Show 18 study locations
Sponsors and Collaborators
AlgiPharma AS
Smerud Medical Research International AS
Layout table for investigator information
Principal Investigator: Tacjana Pressler, PhD MD Rigshospitalet, Denmark
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AlgiPharma AS Identifier: NCT02157922    
Other Study ID Numbers: SMR-2984
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by AlgiPharma AS:
Cystic fibrosis
mucociliary clearance
lung clearance
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases