A Phase 2/3 interventional study of OligoG Dry powder for inhalation in Cystic Fibrosis, sponsored by AlgiPharma AS. Withdrawn at 1 site in Germany. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by AlgiPharma AS · Phase 2/3, Interventional, and Treatment
Randomized, double blind, placebo controlled study. The study has two parts:
Dose-finding part, followed by longer term follow-up (6 months)
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
Browse Cystic Fibrosis studies →AlgiPharma AS is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Matching placebo dry powder for inhalation. OligoG is replaced by lactose. 10 capsules, BID
Drug: OligoG Dry powder for inhalation
17.5 mg OligoG dry powder for inhalation. 10 capsules, BID
Drug: OligoG Dry powder for inhalation
27.5 mg OligoG dry powder for inhalation. 10 capsules, BID
Drug: OligoG Dry powder for inhalation
37.5 mg OligoG dry powder for inhalation. 10 capsules, BID
Drug: OligoG Dry powder for inhalation
10 capsules Dry Powder for Inhalation, BID
Also known as: Placebo dry powder for inhalation
Forced Expiratory Volume in 1 second (FEV1)
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)
Lung Clearance Index (LCI) (Part two only)
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
Sputum culture microbiology
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)
Pulmonary Exacerbations
Acute pulmonary exacerbations
Time frame: Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
Plan to share: No
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This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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AlgiPharma AS