Persistent cough in Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1 Level: LLT Classification code 10070801 Term: Persistent cough System Organ Class: 100000004855
Conditions
Interventions
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
Pharmaceutical Form: Nebulisation solution
INN or Proposed INN: SODIUM CROMOGLICATE
CAS Number: 15826-37
Sponsors
Respivant Sciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Male or female subjects age 40 through 89 years, inclusive 2. Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines for IPF 3. Presence of persistent cough for at least 8 weeks that is primarily due to IPF and not responsive to antitussive therapy 4. Daytime cough severity score of =40 mm on a 100-mm VAS at the Screening Visit 5. 24-hour average cough count of at least 10 coughs per hour using an objective cough-count monitor during Screening 6. Forced Vital Capacity (FVC) = 45% predicted value within 4 weeks of the Screening Visit 7. Diffusion capacity for carbon monoxide corrected for hemoglobin (DLCOc) = 30% predicted value within 4 weeks of the Screening Visit 8. Life expectancy of at least 12 months 9. Willing and able to follow the study required visits and assessments 10. Willing and able to use the cough monitor for 24-hour periods at select study visits 11. Willing and able to provide written informed consent prior to study-related procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could place the subject at risk or compromise the quality of the study data as determined by the investigator 2. Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month of the Screening Visit) 3. An upper or lower respiratory tract infection within 4 weeks of the Screening Visit 4. Acute exacerbation of IPF within 6 months of the Screening Visit (Collard et al., 2016) 5. Lung transplantation expected within 12 months 6. Requiring supplemental O2 = 4 litres/min to maintain peripheral arterial O2 saturation (SpO2) = 88% at rest 7. History of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma, squamous cell, prostate carcinoma or cervical carcinoma in situ) 8. Current smoker (i.e., use of tobacco products within the last 3 months) 9. Current or recent history of drug or alcohol abuse within 12 months of the Screening Visit 10. Participation in any other investigational drug study within 4 weeks of the Screening Visit or within 5 times the elimination half-life of an investigational drug 11. Use of the following drugs for cough management within 4 weeks of the Screening Visit: prednisone, opiates, baclofen, gabapentin, pregabalin, thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators 12. Use of ACE inhibitors or cromolyn sodium within 4 weeks of the Screening Visit 13. Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control during the study (e.g., abstinence, combination barrier and spermicide, hormonal, or male partner sterilization) 14. History of hypersensitivity or intolerance to cromolyn sodium or its inactive ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: • To assess the efficacy of inhaled RVT-1601 in comparison with placebo following 12 weeks of treatment;Secondary Objective: Secondary: • To select the optimal dose of RVT-1601 • To assess the pharmacokinetic (PK) profile of RVT-1601 • To assess biomarker response to RVT-1601 • To assess the impact of RVT-1601 on IPF disease • To assess the safety of RVT-1601;Primary end point(s): Primary endpoint: • Change from baseline at the end of treatment in 24-hour average cough count;Timepoint(s) of evaluation of this end point: Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: • Change from baseline at the end of treatment in cough severity as measured by VAS • Change from baseline at the end of treatment in cough-specific QoL as measured by LCQ • Proportion of responders with a minimum of 20% decrease from baseline at the end of treatment in 24-hour average cough count • Change from baseline at the end of treatment in daytime average cough count • Change from baseline at the end of treatment in nighttime average cough count • Change from baseline at the end of treatment in ILD-specific QoL as measured by K-BILD • Change from baseline at the end of treatment in respiratory-related QoL as measured by SGRQ • Change from baseline at the end of treatment in dyspnea score as measured by SOBQ • Change from baseline at the end of treatment in 6MWT • Change from baseline at the end of treatment in FVC • Proportion of subjects with no decline (i.e., 10% decline in FVC % predicted at the end of treatment • Change from baseline at the end of treatment in airway and lung volumes as measured by FRI • Change from baseline at the end of treatment in average daily oxygen use • Change from baseline at the end of treatment in exploratory biomarkers;Timepoint(s) of evaluation of this end point: Week 12. | — |
Countries
Belgium, Canada, Czech Republic, Germany, Italy, Netherlands, Turkey, United Kingdom, United States
Contacts
Public ContactAhmet Tutuncu
Respivant Sciences, Inc.
Outcome results
None listed