Phase 2

https://clinicaltrials.gov/ct2/show/NCT03756922?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=07%2F18%2F2019&lupd_d=14

Condition :   Cystic Fibrosis

Interventions :   Drug: FDL169;   Drug: FDL176

Sponsor :   Flatley Discovery Lab LLC

Recruiting

A DDI Study of FDL169 and FDL176 in Healthy Subjects

NCT03756922

Wed, 28 Nov 2018 12:00:00 EST

Last Update Posted: 08/01/19 08:36AM

https://clinicaltrials.gov/ct2/show/NCT03822455?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=07%2F03%2F2019&lupd_d=14

Condition :   Cystic Fibrosis

Intervention :   Drug: OligoG DPI

Sponsors :   AlgiPharma AS;   AlgiPharma Australia Pty. Ltd.

Recruiting

A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis

NCT03822455

Wed, 30 Jan 2019 12:00:00 EST

Last Update Posted: 07/17/19 07:52AM

https://clinicaltrials.gov/ct2/show/NCT03925194?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=04%2F10%2F2019&lupd_d=14

Condition :   Cystic Fibrosis, 10011762

Intervention :   Drug: Anakinra

Sponsor :   Heidelberg University

Not yet recruiting

A Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic Fibrosis

NCT03925194

Wed, 24 Apr 2019 12:00:00 EDT

Last Update Posted: 04/24/19 07:50AM

https://clinicaltrials.gov/ct2/show/NCT03768089?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F25%2F2019&lupd_d=14

Condition :   Cystic Fibrosis

Interventions :   Drug: VX-121;   Drug: TEZ/IVA;   Drug: IVA;   Drug: Matched Placebo

Sponsor :   Vertex Pharmaceuticals Incorporated

Active, not recruiting

Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

NCT03768089

Fri, 07 Dec 2018 12:00:00 EST

Last Update Posted: 04/08/19 08:27AM

https://clinicaltrials.gov/ct2/show/NCT03597347?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F20%2F2019&lupd_d=14

Conditions :   Mycobacterium Infections, Nontuberculous;   Cystic Fibrosis (CF)

Interventions :   Drug: Molgramostim nebulizer solution;   Device: PARI eFlow nebulizer system

Sponsor :   Savara Inc.

Not yet recruiting

Trial of Inhaled Molgramostim in CF Subjects With NTM Infection

NCT03597347

Tue, 24 Jul 2018 12:00:00 EDT

Last Update Posted: 04/03/19 07:37AM

https://clinicaltrials.gov/ct2/show/NCT03870841?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=02%2F26%2F2019&lupd_d=14

Conditions :   Aspergillosis;   Cystic Fibrosis

Intervention :   Drug: PC945

Sponsor :   Pulmocide Ltd

Not yet recruiting

The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis

NCT03870841

Tue, 12 Mar 2019 12:00:00 EDT

Last Update Posted: 03/12/19 09:59AM

https://clinicaltrials.gov/ct2/show/NCT03822455

A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis (CFmised, Double-blind, Parallel-group Study of Alginate Oligosaccharide)

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Brief Summary:
A double-blind, randomised study of OligoG DPI compared to placebo DPI, both on top of standard-of-care, to assess safety, efficacy and tolerability. Adult patients with Cystic Fibrosis will be included in the study.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis
Drug: OligoG DPI
Phase 2
Phase 3

Detailed Description:
The alginate oligosaccharide OligoG CF-5/20 dry powder for inhalation (OligoG DPI) represents a novel therapeutic approach for patients with cystic fibrosis (CF). OligoG has been shown to release stagnant mucus, modulate sputum rheology and disrupt the biofilm formation often typically observed in CF. These properties will in turn facilitate mucus clearance and promote effectiveness of antibiotic therapy against the chronic pulmonary infections characteristic of CF.

Patients with CF (age 18 years or older) will be eligible to participate in this study.

The design will be a randomised, blinded, placebo-controlled pilot study for proof of concept that OligoG DPI can improve lung function in adult CF patients. Study medication will be given twice daily for twelve weeks on top of standard of care (SOC). Thirty-three patients will be included, out of which twenty-two shall receive OligoG, and eleven shall receive placebo.

Following a 4 week wash out period, patients will be given open-label OligoG twice daily, in addition to standard of care, for 12 months.

The primary endpoint will be absolute change i percent predicted FEV1

Exploratory parameters will include sputum microbiology.

Study Design
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Study Type : Interventional
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, double blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients will be randomised to receive OligoG or placebo DPI. The investigational medicinal products will have identical appearance
Primary Purpose: Treatment
Official Title: A Phase 2b Randomised, Double-blind, Parallel-group Study of Alginate Oligosaccharide (OligoG) Dry Powder Inhalation in Addition to Standard of Care Compared to Placebo in Addition to Standard of Care in Patients With Cystic Fibrosis (CF)
Estimated Study Start Date : April 3, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019