search
Back to results

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

Primary Purpose

Cystic Fibrosis

Status
Withdrawn
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
OligoG Dry powder for inhalation
Sponsored by
AlgiPharma AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Oligosaccharide

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CF Zentrum Köln, Universitätskrankenhaus Köln

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo DPI

Low dose OligoG DPI

medium dose OligoG DPI

High dose OligoG DPI

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in 1 second (FEV1)
the amount of air a person can forcefully exhale in one second

Secondary Outcome Measures

Lung Clearance Index (LCI) (Part two only)
Lung clearance index (LCI) measured by multiple breath washout is a sensitive measure of ventilation inhomogeneity.
Sputum culture microbiology
Reduction in Pseudomonas Aeruginosa CFU Counts and total counts
Pulmonary Exacerbations
Acute pulmonary exacerbations

Full Information

First Posted
October 3, 2018
Last Updated
June 27, 2022
Sponsor
AlgiPharma AS
Collaborators
Imperial College London, Cystic Fibrosis Foundation, European Cystic Fibrosis Society, University Hospital of Cologne, Cystic Fibrosis Europe
search

1. Study Identification

Unique Protocol Identification Number
NCT03698448
Brief Title
A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis
Acronym
SMR3372
Official Title
A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Determined not feasible
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlgiPharma AS
Collaborators
Imperial College London, Cystic Fibrosis Foundation, European Cystic Fibrosis Society, University Hospital of Cologne, Cystic Fibrosis Europe

4. Oversight

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
Data Monitoring Committee
Yes

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Oligosaccharide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomised, double blind, dose-finding
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo medication with identical appearance to the active drug
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo DPI
Arm Type
Placebo Comparator
Arm Description
Matching placebo dry powder for inhalation. OligoG is replaced by lactose. 10 capsules, BID
Arm Title
Low dose OligoG DPI
Arm Type
Active Comparator
Arm Description
17.5 mg OligoG dry powder for inhalation. 10 capsules, BID
Arm Title
medium dose OligoG DPI
Arm Type
Active Comparator
Arm Description
27.5 mg OligoG dry powder for inhalation. 10 capsules, BID
Arm Title
High dose OligoG DPI
Arm Type
Active Comparator
Arm Description
37.5 mg OligoG dry powder for inhalation. 10 capsules, BID
Intervention Type
Drug
Intervention Name(s)
OligoG Dry powder for inhalation
Other Intervention Name(s)
Placebo dry powder for inhalation
Intervention Description
10 capsules Dry Powder for Inhalation, BID
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
the amount of air a person can forcefully exhale in one second
Time Frame
Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
Secondary Outcome Measure Information:
Title
Lung Clearance Index (LCI) (Part two only)
Description
Lung clearance index (LCI) measured by multiple breath washout is a sensitive measure of ventilation inhomogeneity.
Time Frame
Change from before to after 26 weeks treatment
Title
Sputum culture microbiology
Description
Reduction in Pseudomonas Aeruginosa CFU Counts and total counts
Time Frame
Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
Title
Pulmonary Exacerbations
Description
Acute pulmonary exacerbations
Time Frame
Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silke van Koningsbruggen-Rietschel, MD, PhD
Organizational Affiliation
University Hospital Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CF Zentrum Köln, Universitätskrankenhaus Köln
City
Cologne
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs