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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04318704




Registration number
NCT04318704
Ethics application status
Date submitted
20/03/2020
Date registered
24/03/2020

Titles & IDs
Public title
Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough
Scientific title
An Open Label Study of the Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough
Secondary ID [1] 0 0
AGN120-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ifenprodil

Other: Single Arm Active - Ifenprodil


Treatment: Drugs: Ifenprodil
Ifenprodil 20 mg TID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A =50% reduction in the average number of coughs per hour over 24 hours comparing baseline to treatment period using an ambulatory cough monitor
Timepoint [1] 0 0
Baseline and week 12 (=11 weeks of treatment)
Primary outcome [2] 0 0
No worsening of force vital capacity (FVC) in either mL or % predicted
Timepoint [2] 0 0
Baseline and week 12 (=11 weeks of treatment)

Eligibility
Key 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.
Minimum age
No limit
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/05/2022
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Vale Medical Practice - Brookvale
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Cairns Hospital - Cairns
Recruitment postcode(s) [1] 0 0
- Brookvale
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Cairns
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury
Country [2] 0 0
New Zealand
State/province [2] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Algernon Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04318704