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SMR3372: A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis

Sponsor
AlgiPharma AS (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03698448
Collaborator
Imperial College London (Other), Cystic Fibrosis Foundation (Other), European Cystic Fibrosis Society (Other), University Hospital of Cologne (Other), Cystic Fibrosis Europe (Other)
0
Enrollment
1
Location
4
Arms
14
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Randomized, double blind, placebo controlled study. The study has two parts:

Dose-finding part, followed by longer term follow-up (6 months)

Condition or Disease Intervention/Treatment Phase
  • Drug: OligoG Dry powder for inhalation
 Phase 2/Phase 3

Detailed Description

Part 1: Randomized, double blind, placebo controlled dose-finding. Patients will be assigned to 1 of 3 doses OligoG, or to placebo, on top of Standard of Care. Patients will be treated for 12 weeks, followed by 4 weeks washout.The primary endpoint is relative change in % predicted FEV1. Secondary endpoints include additional spirometry parameters, exacerbation rate, Quality of Life, sputum rheology and microbiology, safety laboratory tests and adverse event reporting.

Part 2: Randomized double-blind 6 -month study, for longer term follow-up of the dose identified in Part 1. New patients will be recruited in part 2, in addition to patients who received placebo in Part 1. In addition to the endpoints studied in Part 1, Part 2 will include Lung Clearance Index (LCI), chest imaging by MRI or CT, and pharmaco-economic parameters.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised, double blind, dose-findingRandomised, double blind, dose-finding
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Placebo medication with identical appearance to the active drug
Primary Purpose:
Treatment
Official Title:
A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo DPI

Matching placebo dry powder for inhalation. OligoG is replaced by lactose. 10 capsules, BID

Drug: OligoG Dry powder for inhalation
10 capsules Dry Powder for Inhalation, BID
Other Names:
  • Placebo dry powder for inhalation

    		•
    Active Comparator: Low dose OligoG DPI

    17.5 mg OligoG dry powder for inhalation. 10 capsules, BID

    Drug: OligoG Dry powder for inhalation
    10 capsules Dry Powder for Inhalation, BID
    Other Names:
  • Placebo dry powder for inhalation

    		•
    Active Comparator: medium dose OligoG DPI

    27.5 mg OligoG dry powder for inhalation. 10 capsules, BID

    Drug: OligoG Dry powder for inhalation
    10 capsules Dry Powder for Inhalation, BID
    Other Names:
  • Placebo dry powder for inhalation

    		•
    Active Comparator: High dose OligoG DPI

    37.5 mg OligoG dry powder for inhalation. 10 capsules, BID

    Drug: OligoG Dry powder for inhalation
    10 capsules Dry Powder for Inhalation, BID
    Other Names:
  • Placebo dry powder for inhalation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Forced Expiratory Volume in 1 second (FEV1) [Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)]

      the amount of air a person can forcefully exhale in one second

    Secondary Outcome Measures

    1. Lung Clearance Index (LCI) (Part two only) [Change from before to after 26 weeks treatment]

      Lung clearance index (LCI) measured by multiple breath washout is a sensitive measure of ventilation inhomogeneity.

    2. Sputum culture microbiology [Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)]

      Reduction in Pseudomonas Aeruginosa CFU Counts and total counts

    3. Pulmonary Exacerbations [Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)]

      Acute pulmonary exacerbations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Confirmed diagnosis of CF

    • FEV1 at screening >40 and < 90% of predicted normal

    • History of PA infection in last 12 m

    • History of antibiotic treatment due tp PA infection (not for eradication) during last 12 m

    • Concomitant inhaled tobramycin, colistin, aztreonam, or levoflaxin (cycled or continuous)

    • Stable CF disease

    • Willing to remain on stable CF medication (Standard of care)

    • Women of child-bearing potential must habe negative urine pregnany test

    • Males & females must use acceptable contraception

    • Capable of inhaling dry powder

    • willing to sign informed consent

    • willing and able to follow study procedures

    Exclusion Criteria:

    • Use of hypertonic saline > twice daily

    • Clinically significant abnormal lab findings, except CRP. In case of high GGT values, case will be discussed by experts before deciding

    • History of comorbidity that may distort results or cause additional risk

    • pulmonary exacerbation within 28 days prior to randomisation

    • Change in CF therapy within 28 days prior to randomisation

    • Burkholderia spp. finding within 12 m prior to screening

    • pregnant or breast feeding females

    • History of allergic reactions to IMP ingredients, incl milk protein

    • Inability to perform lung function tests according to ATS/ ERS criteria

    • Uncontrolled or unstable diseases that might limit compliance

    • History of, or planned organ transplantation

    • Allergic ABPA in the last 12 months prior to the screening visit

    • Requirement for continuous oxygen supplementation

    • Current participation in another clinical study

    • medical condition, other than CFwhich exposes the patient to an unacceptably high risk

    • Concurrent mlignant disease, except BCC and cervical neoplasia

    • Clinically significant alcohol or drug abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CF Zentrum Köln, Universitätskrankenhaus Köln Cologne Germany 50924

    Sponsors and Collaborators

    • AlgiPharma AS
    • Imperial College London
    • Cystic Fibrosis Foundation
    • European Cystic Fibrosis Society
    • University Hospital of Cologne
    • Cystic Fibrosis Europe

    Investigators

    • Principal Investigator: Silke van Koningsbruggen-Rietschel, MD, PhD, University Hospital Cologne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AlgiPharma AS
    ClinicalTrials.gov Identifier:
    NCT03698448
    Other Study ID Numbers:
    • 3372
    • 2018-000378-30
    First Posted:
    Oct 9, 2018
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AlgiPharma AS
    Oligosaccharide
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Jun 30, 2022