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Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04318704
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : October 20, 2021
Information provided by (Responsible Party):
Algernon Pharmaceuticals

Brief Summary:
NP-120 (Ifenprodil) has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of Idiopathic Pulmonary Fibrosis (IPF). In addition, NP-120 significantly reduced both cough frequency and onset in a guinea pig tussive model. The purpose of this proof-of-concept trial is to determine the efficacy of NP-120 in the treatment of IPF and its associated cough.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Ifenprodil Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of the Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Single Arm Active
Drug: Ifenprodil
Ifenprodil 20 mg TID

Primary Outcome Measures :
  1. A ≥50% reduction in the average number of coughs per hour over 24 hours comparing baseline to treatment period using an ambulatory cough monitor [ Time Frame: Baseline and week 12 (≥11 weeks of treatment) ]
  2. No worsening of force vital capacity (FVC) in either mL or % predicted [ Time Frame: Baseline and week 12 (≥11 weeks of treatment) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female subjects with a diagnosis of IPF established during the previous seven years according to ATS/ERS/Fleischner criteria.
  2. Score ≥ 40 mm on the Cough Severity VAS at Screening
  3. Lung function parameters as follows:

    1. Forced Vital Capacity (FVC) ≥ 45% of the predicted value at screening.
    2. Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to 79% of the predicted value at screening.
  4. Any existing Standard of Care (SoC) treatment (e.g. pirfenidone or nintedanib) must be deemed as stable (minimum three months) before enrollment.
  5. Subjects must sign and date a written, informed consent form and any required authorization prior to initiation of any study procedures.

Exclusion Criteria:

  1. Currently has significant airways obstruction: Forced Expiratory Volume in 1 s (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening.
  2. Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis.
  3. Has a history of malignancy within the last 2 years with the exception of basal cell carcinoma, chronic lymphocytic leukaemia (under observation) and prostate cancer requiring anti-androgens, localised treatment (minor surgery, radiotherapy) and/or managed by observation, and squamous cell carcinoma if diagnosed and successfully treated more than 6 months prior to the study. SCC diagnosed with the past 6 months will be exclusionary.
  4. Patients experiencing cerebral hemorrhage or cerebral infarction at screening/baseline.
  5. Has any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the subject within the next 2 years.
  6. Presence of other disease that may interfere with testing procedures or in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
  7. Is likely to receive lung transplantation within the next 12 months.
  8. Currently receiving high dose corticosteroid, cytotoxic (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g., bosentan), and or investigational therapy for idiopathic pulmonary fibrosis (IPF) or administration of such therapeutics within 4 weeks of initial screening (or 5 half-lives, whichever is longer). A current dose of less than or equal to 15 mg/day of prednisone or its equivalent is acceptable if the dose is anticipated to remain stable during the study.
  9. Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous six months, including, but not limited to, the following:

    1. Unstable angina pectoris or myocardial infarction, or percutaneous coronary intervention within the last 6 months,
    2. Congestive heart failure requiring hospitalization,
    3. Uncontrolled clinically significant arrhythmias.
  10. If female, the subject is pregnant or lactating or intending to become pregnant before participating in this study during the study and within (5 half- lives plus 30 days) after last dose of the study drug; or intending to donate ova during such time period.
  11. Women considered to be of childbearing potential who do not use highly effective birth control methods during the study.
  12. Known or suspected allergy to the trial drug or the relevant drugs given in the trial.
  13. Involvement in a clinical research study within 4 weeks prior to screening and/or prior enrollment in the study. Participation in registry studies is permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04318704

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Contact: Nancy Stewart, Ph.D. 204-928-7905

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Australia, New South Wales
Vale Medical Practice Recruiting
Brookvale, New South Wales, Australia
Contact: Naomi DeFazio    61298556000   
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia
Contact: Elizabeth Vietch    61297675000   
Contact: Kerrie Wade    61297676334   
Westmead Hospital Recruiting
Westmead, New South Wales, Australia
Contact: Rita (Perri) Ginn, MSc    (+612) 8890 7366   
Australia, Queensland
Cairns Hospital Recruiting
Cairns, Queensland, Australia
Contact: Clinical Research Unit    61742268085   
New Zealand
The University of Otago Recruiting
Christchurch, Canterbury, New Zealand
Contact: Lutz Beckert    0064033640640   
Contact: Liz Cousins    03364640   
Waikato Hospital Recruiting
Hamilton, Waikato, New Zealand
Contact: Catherina Chang    (64) 078398899   
Contact: Christine Tuffery    (64) 21759531   
Sponsors and Collaborators
Algernon Pharmaceuticals
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Responsible Party: Algernon Pharmaceuticals Identifier: NCT04318704    
Other Study ID Numbers: AGN120-1
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Algernon Pharmaceuticals:
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents