Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial
- Conditions
- Idiopathic Pulmonary Fibrosispersistent cough10024967
- Registration Number
- NL-OMON48040
- Lead Sponsor
- Respivant Sciences GmBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
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. Life expectancy of at least 12 months
8. Willing and able to follow the study required visits and assessments.
9. 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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline at the end of treatment in 24-hour average cough count </p><br>
- Secondary Outcome Measures
Name Time Method