Clinical Trials
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People With Cystic Fibrosis (ABCI)
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
https://clinicaltrials.gov/ct2/show/NCT04043806
https://clinicaltrials.gov/ct2/show/NCT04043806?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=07%2F19%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: ELX/TEZ/IVA; Drug: IVA
Sponsor : Vertex Pharmaceuticals Incorporated
Not yet recruiting
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
NCT04043806
Fri, 02 Aug 2019 12:00:00 EDT
Last Update Posted: 08/02/19 07:07AM
Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations
https://clinicaltrials.gov/ct2/show/NCT03624101?recrs=abdf
https://clinicaltrials.gov/ct2/show/NCT03624101?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=05%2F15%2F2020&lupd_d=14
Condition : Cystic Fibrosis
Intervention : Drug: Tezacaftor/Ivacaftor
Sponsor : University of Alabama at Birmingham
Recruiting
Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations
NCT03624101
Thu, 09 Aug 2018 12:00:00 EDT
Last Update Posted: 05/29/20 06:52AM
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
https://clinicaltrials.gov/ct2/show/NCT04058353?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=08%2F01%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: ELX/TEZ/IVA; Drug: IVA; Drug: TEZ/IVA
Sponsor : Vertex Pharmaceuticals Incorporated
Not yet recruiting
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
NCT04058353
Thu, 15 Aug 2019 12:00:00 EDT
Last Update Posted: 08/15/19 07:38AM
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes
https://clinicaltrials.gov/ct2/show/NCT04353817?recrs=abdf
https://clinicaltrials.gov/ct2/show/NCT04353817?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=04%2F06%2F2020&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: ELX/TEZ/IVA; Drug: IVA; Other: Placebo
Sponsor : Vertex Pharmaceuticals Incorporated
Not yet recruiting
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes
NCT04353817
Mon, 20 Apr 2020 12:00:00 EDT
Last Update Posted: 04/20/20 07:17AM
Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)
https://clinicaltrials.gov/ct2/show/NCT02323100?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F19%2F2020&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: Ravicti low dose; Drug: Ravicti high dose; Drug: Placebo
Sponsors : National Jewish Health; University of Alabama at Birmingham; Children’s Hospital of Philadelphia; Johns Hopkins University; Horizon Pharma Ireland, Ltd., Dublin Ireland
Recruiting
Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)
NCT02323100
Tue, 23 Dec 2014 12:00:00 EST
Last Update Posted: 04/02/20 09:29AM
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
https://clinicaltrials.gov/ct2/show/NCT04105972?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=09%2F12%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: ELX/TEZ/IVA; Drug: TEZ/IVA; Drug: IVA
Sponsor : Vertex Pharmaceuticals Incorporated
Not yet recruiting
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
NCT04105972
Thu, 26 Sep 2019 12:00:00 EDT
Last Update Posted: 09/26/19 07:47AM
Study to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs
https://clinicaltrials.gov/ct2/show/NCT03587961?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=09%2F16%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Intervention : Drug: Symdeko
Sponsor : University of Alabama at Birmingham
Recruiting
Personalized Theratyping Trial
NCT03587961
Mon, 16 Jul 2018 12:00:00 EDT
Last Update Posted: 09/30/19 07:44AM
Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03140527?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=08%2F26%2F2019&lupd_d=14
Conditions : Healthy Volunteer; Cystic Fibrosis
Interventions : Drug: PTI-801; Drug: Placebo; Drug: PTI-808
Sponsor : Proteostasis Therapeutics, Inc.
Recruiting
Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis
NCT03140527
Thu, 04 May 2017 12:00:00 EDT
Last Update Posted: 09/09/19 10:07AM
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
https://clinicaltrials.gov/ct2/show/NCT04058366?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=08%2F01%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: ELX/TEZ/IVA; Drug: IVA
Sponsor : Vertex Pharmaceuticals Incorporated
Not yet recruiting
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
NCT04058366
Thu, 15 Aug 2019 12:00:00 EDT
Last Update Posted: 08/15/19 07:38AM
A DDI Study of FDL169 and FDL176 in Healthy Subjects
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
A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis
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
A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF)
https://clinicaltrials.gov/ct2/show/NCT04010799?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=06%2F24%2F2019&lupd_d=14
Conditions : Cystic Fibrosis; Non-Cystic Fibrosis Bronchiectasis
Interventions : Drug: CHF 6333; Drug: Placebo
Sponsor : Chiesi Farmaceutici S.p.A.
Recruiting
A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis
NCT04010799
Mon, 08 Jul 2019 12:00:00 EDT
Last Update Posted: 07/08/19 07:51AM
Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03058068?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=06%2F10%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Biological: Allo-hMSCs; Biological: Placebo
Sponsor : Joshua M Hare
Not yet recruiting
Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis
NCT03058068
Mon, 20 Feb 2017 12:00:00 EST
Last Update Posted: 06/24/19 07:42AM
Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03251092?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=06%2F04%2F2019&lupd_d=14
Conditions : Healthy Volunteer – Complete; Cystic Fibrosis
Interventions : Drug: PTI-808; Drug: Placebo; Drug: PTI-428; Drug: PTI-801
Sponsor : Proteostasis Therapeutics, Inc.
Recruiting
Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis
NCT03251092
Wed, 16 Aug 2017 12:00:00 EDT
Last Update Posted: 06/18/19 07:04AM
Glycerol Phenylbutyrate Corrector Therapy [Ravicti] For CF (Cystic Fibrosis)
https://clinicaltrials.gov/ct2/show/NCT02323100?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=05%2F28%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: Ravicti low dose; Drug: Ravicti high dose; Drug: Placebo
Sponsors : National Jewish Health; University of Alabama at Birmingham; Children’s Hospital of Philadelphia; Johns Hopkins University; Horizon Pharma Ireland, Ltd., Dublin Ireland
Recruiting
Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)
NCT02323100
Tue, 23 Dec 2014 12:00:00 EST
Last Update Posted: 06/11/19 07:02AM
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
https://clinicaltrials.gov/ct2/show/NCT03969888?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=05%2F17%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: ABBV-3067; Drug: Placebo ABBV-3067; Drug: ABBV-2222; Drug: Placebo ABBV-2222
Sponsor : AbbVie
Not yet recruiting
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
NCT03969888
Fri, 31 May 2019 12:00:00 EDT
Last Update Posted: 05/31/19 07:15AM
Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations
https://clinicaltrials.gov/ct2/show/NCT03624101?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=05%2F03%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Intervention : Drug: Tezacaftor/Ivacaftor
Sponsor : University of Alabama at Birmingham
Recruiting
Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations
NCT03624101
Thu, 09 Aug 2018 12:00:00 EDT
Last Update Posted: 05/17/19 07:16AM
Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients
https://clinicaltrials.gov/ct2/show/NCT02598999?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=04%2F17%2F2019&lupd_d=14
Conditions : Cystic Fibrosis; Bronchiectasis
Interventions : Drug: ALX-009; Drug: OSCN-; Drug: bLF; Drug: Placebo
Sponsor : Alaxia SAS
Recruiting
Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients
NCT02598999
Fri, 06 Nov 2015 12:00:00 EST
Last Update Posted: 05/01/19 07:29AM
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
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
iPS Cell Response to CFTR Modulators
https://clinicaltrials.gov/ct2/show/NCT03506061?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=04%2F02%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Intervention : Drug: Orkambi
Sponsors : Emory University; National Heart, Lung, and Blood Institute (NHLBI)
Not yet recruiting
iPS Cell Response to CFTR Modulators
NCT03506061
Mon, 23 Apr 2018 12:00:00 EDT
Last Update Posted: 04/16/19 09:05AM
A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03912233?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F28%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: VX-121; Drug: TEZ; Drug: VX-561; Drug: TEZ/IVA; Drug: IVA; Drug: Placebo
Sponsor : Vertex Pharmaceuticals Incorporated
Not yet recruiting
A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis
NCT03912233
Thu, 11 Apr 2019 12:00:00 EDT
Last Update Posted: 04/11/19 08:16AM
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03911713?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F28%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: VX-561; Drug: IVA; Drug: Placebo
Sponsor : Vertex Pharmaceuticals Incorporated
Not yet recruiting
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
NCT03911713
Thu, 11 Apr 2019 12:00:00 EDT
Last Update Posted: 04/11/19 08:16AM
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT01851694?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F27%2F2019&lupd_d=14
Conditions : Cystic Fibrosis; Pancreatic Insufficiency
Interventions : Drug: GLP-1; Drug: GIP
Sponsors : University of Pennsylvania; Children’s Hospital of Philadelphia
Recruiting
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
NCT01851694
Fri, 10 May 2013 12:00:00 EDT
Last Update Posted: 04/10/19 08:33AM
Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis
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
A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients
https://clinicaltrials.gov/ct2/show/NCT03181932?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F21%2F2019&lupd_d=14
Conditions : MRSA; Cystic Fibrosis
Interventions : Drug: Vancomycin inhalation powder; Drug: Placebo inhalation powder
Sponsor : Savara Inc.
Recruiting
A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients
NCT03181932
Fri, 09 Jun 2017 12:00:00 EDT
Last Update Posted: 04/04/19 07:50AM
Effect of Losartan in Cystic Fibrosis (CF)
https://clinicaltrials.gov/ct2/show/NCT03435939?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F21%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Intervention : Drug: Losartan
Sponsor : University of Kansas Medical Center
Not yet recruiting
Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240
NCT03435939
Fri, 16 Feb 2018 12:00:00 EST
Last Update Posted: 04/04/19 07:50AM
Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03903913?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F21%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Intervention : Drug: S-1226
Sponsor : SolAeroMed Inc.
Not yet recruiting
Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis
NCT03903913
Thu, 04 Apr 2019 12:00:00 EDT
Last Update Posted: 04/04/19 07:50AM
Trial of Inhaled Molgramostim in CF Subjects With NTM Infection
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
Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi
https://clinicaltrials.gov/ct2/show/NCT03894657?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F14%2F2019&lupd_d=14
Conditions : Cystic Fibrosis; Homozygous F508del Mutation
Interventions : Diagnostic Test: Nasal brushing; Other: Sputum sample; Other: blood sample; Drug: Orkambi
Sponsor : Assistance Publique – Hôpitaux de Paris
Not yet recruiting
Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®.
NCT03894657
Thu, 28 Mar 2019 12:00:00 EDT
Last Update Posted: 03/28/19 09:25AM
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03375047?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F07%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: MRT5005; Drug: Normal saline
Sponsor : Translate Bio, Inc.
Recruiting
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis
NCT03375047
Fri, 15 Dec 2017 12:00:00 EST
Last Update Posted: 03/21/19 09:54AM
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03229252?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F05%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: Placebo Inhalation Solution; Drug: SPX-101
Sponsor : Spyryx Biosciences, Inc.
Recruiting
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
NCT03229252
Tue, 25 Jul 2017 12:00:00 EDT
Last Update Posted: 03/19/19 09:26AM
The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis
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
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Patients With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03647228?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=02%2F22%2F2019&lupd_d=14
Condition : Healthy Subjects
Interventions : Drug: IONIS-ENaCRx; Drug: Placebo
Sponsor : Ionis Pharmaceuticals, Inc.
Recruiting
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis
NCT03647228
Mon, 27 Aug 2018 12:00:00 EDT
Last Update Posted: 03/08/19 11:56AM
A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation
https://clinicaltrials.gov/ct2/show/NCT03537651?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=02%2F15%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: TEZ; Drug: IVA
Sponsor : Vertex Pharmaceuticals Incorporated
Active, not recruiting
A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation
NCT03537651
Fri, 25 May 2018 12:00:00 EDT
Last Update Posted: 03/01/19 05:18PM
SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects
https://clinicaltrials.gov/ct2/show/NCT03669614?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=02%2F12%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: inhaled AR-501; Drug: inhaled AR-501 placebo
Sponsor : Aridis Pharmaceuticals, Inc.
Recruiting
SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects
NCT03669614
Thu, 13 Sep 2018 12:00:00 EDT
Last Update Posted: 02/26/19 10:27AM
A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
https://clinicaltrials.gov/ct2/show/NCT03447262?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=02%2F04%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: VX-659; Drug: TEZ; Drug: IVA
Sponsor : Vertex Pharmaceuticals Incorporated
Enrolling by invitation
A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
NCT03447262
Tue, 27 Feb 2018 12:00:00 EST
Last Update Posted: 02/18/19 10:26AM
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
https://clinicaltrials.gov/ct2/show/NCT03525574?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=02%2F04%2F2019&lupd_d=14
Condition : Cystic Fibrosis
Interventions : Drug: VX-445; Drug: TEZ; Drug: IVA
Sponsor : Vertex Pharmaceuticals Incorporated
Enrolling by invitation
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
NCT03525574
Tue, 15 May 2018 12:00:00 EDT
Last Update Posted: 02/18/19 10:26AM
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis (OPTION)
https://clinicaltrials.gov/ct2/show/NCT03746483
Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic Fibrosis (CEASE-CF)
https://clinicaltrials.gov/ct2/show/NCT02866721
Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults (APPLAUD)
https://clinicaltrials.gov/ct2/show/NCT03265288
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03451045
Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/study/NCT03251092
A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis (CFmised, Double-blind, Parallel-group Study of Alginate Oligosaccharide)
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
Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03500263
Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations
https://clinicaltrials.gov/ct2/show/NCT03624101
Personalized Theratyping Trial
https://clinicaltrials.gov/ct2/show/NCT03587961
Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT03768089
Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis (HAPI)
https://clinicaltrials.gov/ct2/show/NCT03058068
A DDI Study of FDL169 and FDL176 in Healthy Subjects
https://clinicaltrials.gov/ct2/show/NCT03756922
Sponsor:
Flatley Discovery Lab LLC
Information provided by (Responsible Party):
Flatley Discovery Lab LLC
Brief Summary:
A DDI study to assess the safety, tolerability and pharmacokinetics of both; doses of FDL176 with and without co-administration of FDL169 and doses of FDL169 with and without co-administration of FDL176.
Condition or disease Intervention/treatment Phase
Cystic Fibrosis
Drug: FDL169
Drug: FDL176
Phase 1
Detailed Description:
This is an open-label, non-randomised study. Enrolment will be in two parallel and independent parts. Part 1 will assess the safety, tolerability and pharmacokinetics of single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the safety, tolerability and pharmacokinetics of repeated doses of FDL169 with and without co-administration of FDL176.
Study Design
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019
Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF
https://clinicaltrials.gov/ct2/show/NCT03748199
Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis
https://clinicaltrials.gov/ct2/show/NCT02566044
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis (RESTORE-CF)
https://clinicaltrials.gov/ct2/show/NCT03375047