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

NCT03698448 | Withdrawn Phase 2 DMC

• 2 other identifiers: 33722018-000378-30
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double blind, placebo controlled study. The study has two parts: Dose-finding part, followed by longer term follow-up (6 months)

Conditions

Cystic Fibrosis

Keywords

Oligosaccharide

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 second (FEV1)

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

  Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)

Secondary Outcomes (3)

• Lung Clearance Index (LCI) (Part two only)

  Change from before to after 26 weeks treatment

• Sputum culture microbiology

  Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)

• Pulmonary Exacerbations

  Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)

Study Arms (4)

Placebo DPI

PLACEBO COMPARATOR

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

Drug: OligoG Dry powder for inhalation

Low dose OligoG DPI

ACTIVE COMPARATOR

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

Drug: OligoG Dry powder for inhalation

medium dose OligoG DPI

ACTIVE COMPARATOR

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

Drug: OligoG Dry powder for inhalation

High dose OligoG DPI

ACTIVE COMPARATOR

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

Drug: OligoG Dry powder for inhalation

Interventions

OligoG Dry powder for inhalation DRUG

10 capsules Dry Powder for Inhalation, BID

Also known as: Placebo dry powder for inhalation

High dose OligoG DPI; Low dose OligoG DPI; Placebo DPI; medium dose OligoG DPI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

CF Zentrum Köln, Universitätskrankenhaus Köln

Cologne, 50924, Germany

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Inhalation

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

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Silke van Koningsbruggen-Rietschel, MD, PhD

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo medication with identical appearance to the active drug
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, double blind, dose-finding

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: September 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)