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

Cystic Fibrosis Clinical Trial

— SMR3372  

Official title:

A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03698448
• Other study ID #: 3372
• Secondary ID: 2018-000378-30
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: September 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: June 2022
• Source: AlgiPharma AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• OligoG Dry powder for inhalation
10 capsules Dry Powder for Inhalation, BID

Locations

Country	Name	City	State
Germany	CF Zentrum Köln, Universitätskrankenhaus Köln	Cologne

Sponsors (6)

Lead Sponsor	Collaborator
AlgiPharma AS	Cystic Fibrosis Europe, Cystic Fibrosis Foundation, European Cystic Fibrosis Society, Imperial College London, University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lung Clearance Index (LCI) (Part two only)	Lung clearance index (LCI) measured by multiple breath washout is a sensitive measure of ventilation inhomogeneity.	Change from before to after 26 weeks treatment
Secondary	Sputum culture microbiology	Reduction in Pseudomonas Aeruginosa CFU Counts and total counts	Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
Secondary	Pulmonary Exacerbations	Acute pulmonary exacerbations	Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)