Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)
Lead Sponsor:
Melius Pharma AB
Conditions:
Idiopathic Pulmonary Fibrosis
Cough
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Orally administered ME-015 (Suplatast Tosilate) has been available on the market as a prescription drug for allergy-related conditions in Japan since 1995 with a good safety and tolerability profile. ...
Detailed Description
This quadruple blinded, cross-over, placebo-controlled clinical trial will randomize patients with stable idiopathic pulmonary fibrosis (IPF) and cough related to IPF (IPF cough) in a 1:1 fashion to o...
Eligibility Criteria
Inclusion
- Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines, confirmed by high-resolution computed tomography (HRCT) chest scan taken \< 2 years ago
- Age ≥ 18 years
- Cough attributed to IPF unresponsive to standard anti-tussive treatment and present for \> 8 weeks
- Arithmetic mean of ≥ 10 coughs/hour during waking hours
- Ability to read, comprehend, and complete the ICF and all questionnaires in the study without help
- Cough severity score of ≥ 40 mm on a 0-to-100 mm Visual Analogue Scale (VAS)
- Willing and able to comply with the protocol
- Life expectancy \> 6 months
- Stable medical condition: stable treatment for \> 12 weeks and absence of acute exacerbations for \> 4 weeks
- FVC ≥ 40% predicted
- FEV1 / FVC ≥ 65%
- Women of childbearing potential must agree to use a highly effective method of contraception
- Male partner must agree to use a condom during the study, unless they had a vasectomy \> 6 months prior to first study drug administration
Exclusion
- Likely need for lung transplantation in next 12 months
- Permanent long-term oxygen therapy
- Use of high-dose corticosteroids or cytotoxic medications
- History of unstable or deteriorating cardiac or pulmonary disease in the preceding 6 months
- Current smoking, vaping, or tobacco chewing
- Treatment with an ACE inhibitor or sitagliptin
- Any antitussive treatment, including opioid-based and OTC, for treatment of cough within 4 weeks of Screening or at any point during the study
- BMI \< 18 kg/m2 or ≥ 40 kg/m2
- Suspected acute infection, including COVID-19 or influenza or any upper respiratory tract infection
- History of malignancy within the last 2 years
- History of drug/ alcohol dependency/ abuse within the last 2 years
- Condition that could affect drug absorption
- Recent history of stroke or TIA
- Resting blood pressure \> 160/90 mmHg
- Pregnant/lactating women
- Investigational drug or biologic within the last 2 months
- Blood donation within the last 56 days or plasma donation within the last 7 days
- Severe medical/ psychiatric condition posing risk to trial participation
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05983471
Start Date
April 1 2024
End Date
September 1 2025
Last Update
April 9 2025
Active Locations (6)
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1
Aditya Multi Specialty Hospital
Guntur, Andhra Pradesh, India, 522001
2
KLE's Dr Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, India, 590010
3
ACE Hospital and Research Centre
Pune, Maharashtra, India, 411004
4
Hindusthan Hospital
Coimbatore, Tamil Nadu, India, 641028