A clinical trial to study the safety and effectiveness of ME-015 (Suplatast Tosilate) in cough related to Idiopathic Pulmonary Fibrosis disease, a disease that causes scarring (fibrosis) of the lungs
- Conditions
- Health Condition 1: R05- CoughHealth Condition 2: J841- Other interstitial pulmonary diseases with fibrosis
- Registration Number
- CTRI/2024/01/061637
- Lead Sponsor
- Syngene International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Diagnosis of IPF according to the 2018 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline (2018) with additional confirmation of the diagnosis by independent central review of a high-resolution computed tomography (HRCT) chest scan taken within 2 years prior to screening.
2. Male or female patients aged =18 years.
3. Cough that is attributed to IPF, which has not responded to standard anti-tussive treatment, and which has been present for at least 8 weeks prior to Screening.
4. An arithmetic mean of = 10 coughs/hour objectively assessed using the Vitalojak device during waking hours.
5. Patients need to command a level of literacy that allows them to read, comprehend, and complete the ICF and all questionnaires in the study without help. Patients with a Legally Authorised Representative (LAR) should not be enrolled since all patients are adults and are required to give informed consent themselves.
6. A cough severity score of = 40 mm on a standardized 100 mm Visual Analogue Scale (VAS) at visit S1, S2 and V1.
7. Willing and able to comply with all aspects of the protocol and must provide written informed consent.
8. Life expectancy of greater than 6 months as judged by the investigator.
9. Stable medical condition defined by stable treatment for the last 12 weeks and absence of any acute IPF exacerbations for at least 4 weeks at both Screening and Randomization.
10. Forced vital capacity (FVC) = 40% predicted normal at Screening.
11. A ratio of forced expiratory volume in one second over forced vital capacity (FEV1/FVC) = 65% at Screening.
12. Women of child bearing potential must practice abstinence (if that is their preferred lifestyle) from S1 to Visit 7 , or must agree to use a highly effective method of contraception with a failure rate of <1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device or intrauterine hormone-releasing system) until 3 months after the
last dose of study drug . Their male partner must agree to use a condom during the same time frame, unless he has had a demonstrated successful vasectomy more than 6 months prior to first IMP administration.
13. Males should use condom and their female partner of child-bearing potential must use a
contraceptive method with a failure rate of <1% to prevent pregnancy from Screening until 3 months after the last dose of study drug.
Inclusion criterion #4 will first be verified several days after randomization due to analysis lead times. Subjects meeting all other inclusion criteria and not meeting any exclusion criterion will be randomized into the trial before inclusion criterion #4 can be verified.
1. Likely to receive lung transplantation within the next 12 months.
2. Requires permanent long term oxygen therapy.
3. Currently receiving high dose corticosteroids, cytotoxic treatment (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g., bosentan), and/or investigational therapy for IPF within 12 weeks of 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. Antifibrotic medication (pirfenidone or nintedanib) is allowed if the patient has
been on a stable dose for at least 12 weeks and remains on a stable dose throughout the study.
4. Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months.
5. Current smoker, vaping, and tobacco chewing (i.e., within the last 2 months).
6. Initiation of treatment with an ACE-inhibitor or sitagliptin within 12 weeks prior to the Baseline Visit or during the study.
7. Use of codeine, amitriptyline, gabapentin, pregabalin, opioids and other narcotic antitussives, baclofen, benzonatate, dextromethorphan, carbetapentane, H1 antihistamines, leukotriene modifiers, and cromolyn sodium or any other anti-tussive, for treatment of cough within 4 weeks of the Screening visit or at any point during the study. Cough syrups, over-the-counter herbal or other remedies for the treatment of cough must be stopped at least 2 weeks prior to Baseline and are prohibited during the entire duration of the study. Stable
treatment ( >12 weeks) with inhaled corticosteroid LAMA, LABA or its combination is allowed; however, patients must follow washout restrictions 24 hours for once daily medications and 12 hours for twice daily medications before a scheduled spirometry assessment.
8. Body Mass Index (BMI) <18 kg/m2 or = 40 kg/m2 .
9. Known or suspected acute infection, including COVID-19 or influenza or any upper respiratory tract infection, at the time of Screening or within 4 weeks of the Baseline Visit.
10. History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including patients with <3 excised basal cell carcinomas).
11. History of drug or alcohol dependency or abuse within the last 2 years.
12. Any condition that, in the opinion of the investigator, affects drug absorption (e.g., gastrectomy, gastroplasty, any type of bariatric surgery, vagotomy, or bowel resection).
13. Recent history of stroke or transient ischeimic attack (within 6 months prior to screening).
14. Resting screening systolic blood pressure (SBP) > 160 mmHg or a diastolic blood pressure (DBP) >90 mmHg.
15. Pregnant and Lactating females.
16. Treatment with an investigational drug or biologic within 2 months of Screening and/or plans to take another investigational drug or biologic within 30 days of study completion.
17. Blood donation within 56 days or plasma donation within 7 days prior to baseline.
18. Severe, acute, or chronic medical or psychiatric conditions or significant laboratory abnormalities at Screening that may, in the opinion of the investigator, increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of tr
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Waking time cough frequency measured as change in geometric mean cough count per hour during waking hours from baseline to Day 14 in each treatment period assessed using Vitalojak®, an automatic device that allows objective recording of 24-hour cough frequency. Vitalojak® recordings are analyzed using a centralized, blinded, independent review process.Timepoint: From Baseline to Day 14 in each treatment period
- Secondary Outcome Measures
Name Time Method Cough severity & quality of life measured as change from baseline to Day 14 in each treatment period using the following patient-reported outcome measures (questionnaires): <br/ ><br>1. Visual Analogue Scale, VAS (0-100 mm) <br/ ><br>2. Leicester Cough Questionnaire, LCQ, Score <br/ ><br>3. Global rating of change scale, GRCS. <br/ ><br>4. Cough hypersensitivity questionnaire- CHQ <br/ ><br>5. Dyspnea-12 ScaleTimepoint: From Baseline to Day 14 in each treatment period