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. |
ClinicalTrials.gov Identifier: NCT04318704 |
Recruitment Status :
Recruiting
First Posted : March 24, 2020
Last Update Posted : December 10, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis | Drug: Ifenprodil | Phase 2 |
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 2021 |
Estimated Study Completion Date : | June 2021 |

Arm | Intervention/treatment |
---|---|
Single Arm Active
Ifenprodil
|
Drug: Ifenprodil
Ifenprodil 20 mg TID |
- 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) ]
- No worsening of force vital capacity (FVC) in either mL or % predicted [ Time Frame: Baseline and week 12 (≥11 weeks of treatment) ]

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.
Ages Eligible for Study: | up to 85 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female subjects with a diagnosis of IPF established during the previous seven years according to ATS/ERS/Fleischner criteria.
- Score ≥ 40 mm on the Cough Severity VAS at Screening
-
Lung function parameters as follows:
- Forced Vital Capacity (FVC) ≥ 45% of the predicted value at screening.
- Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to 79% of the predicted value at screening.
- Any existing Standard of Care (SoC) treatment (e.g. pirfenidone or nintedanib) must be deemed as stable (minimum three months) before enrollment.
- Subjects must sign and date a written, informed consent form and any required authorization prior to initiation of any study procedures.
Exclusion Criteria:
- Currently has significant airways obstruction: Forced Expiratory Volume in 1 s (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening.
- Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis.
- 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.
- Patients experiencing cerebral hemorrhage or cerebral infarction at screening/baseline.
- 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.
- 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.
- Is likely to receive lung transplantation within the next 12 months.
- 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.
-
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:
- Unstable angina pectoris or myocardial infarction, or percutaneous coronary intervention within the last 6 months,
- Congestive heart failure requiring hospitalization,
- Uncontrolled clinically significant arrhythmias.
- 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.
- Women considered to be of childbearing potential who do not use highly effective birth control methods during the study.
- Known or suspected allergy to the trial drug or the relevant drugs given in the trial.
- 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.

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 ClinicalTrials.gov identifier (NCT number): NCT04318704
Contact: Nancy Stewart, Ph.D. | 204-928-7905 | nstewart@gvicds.com |
Australia, New South Wales | |
Vale Medical Practice | Recruiting |
Brookvale, New South Wales, Australia | |
Contact: Naomi DeFazio 61298556000 NDeFazio@sonicclinicaltrials.com | |
Concord Repatriation General Hospital | Recruiting |
Concord, New South Wales, Australia | |
Contact: Elizabeth Vietch 61297675000 elizabeth.veich@health.nsw.gov.au | |
Contact: Kerrie Wade 61297676334 kerrie.wade@health.nsw.gov.au | |
Australia, Queensland | |
Cairns Hospital | Recruiting |
Cairns, Queensland, Australia | |
Contact: Clinical Research Unit 61742268085 CairnsCRU@health.qld.gov.au | |
New Zealand | |
The University of Otago | Recruiting |
Christchurch, Canterbury, New Zealand | |
Contact: Lutz Beckert 0064033640640 Lutz.Beckert@cdhb.health.nz | |
Contact: Liz Cousins 03364640 liz.cousins@otago.ac.nz | |
Waikato Hospital | Recruiting |
Hamilton, Waikato, New Zealand | |
Contact: Catherina Chang (64) 078398899 cat.chang@waikatodhb.health.nz | |
Contact: Christine Tuffery 964) 21759531 christine.tuffery@waikatodhb.health.nz |
Responsible Party: | Algernon Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04318704 |
Other Study ID Numbers: |
AGN120-1 |
First Posted: | March 24, 2020 Key Record Dates |
Last Update Posted: | December 10, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cough |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Lung Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial Pathologic Processes Respiratory Tract Diseases Ifenprodil |
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 |