Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Respivant Sciences GmbH
With
Respivant Sciences Inc.
Age
40–89
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects age 40 through 89 years
Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines
Persistent cough for at least 8 weeks that is primarily due to IPF and not responsive to anti-tussive therapy
Daytime cough severity score of ≥ 40 mm on a 100-mm VAS
24-hour average cough count of at least 10 coughs per hour
Forced Vital Capacity (FVC) \> 45% predicted value within 4 weeks
Diffusion capacity for carbon monoxide corrected for hemoglobin (DLCOc) \> 30% predicted value within 4 weeks
Life expectancy of at least 12 months
You may not be if
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
Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month)
Upper or lower respiratory tract infection within 4 weeks
Acute exacerbation of IPF within 6 months
Lung transplantation expected within 12 months
Requiring supplemental O2 \> 4 litres/min to maintain peripheral arterial O2 saturation (SpO2) \> 88% at rest
History of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years
Current smoker (i.e., use of tobacco products within the last 3 months)
Current or recent history of drug or alcohol abuse within 12 months
Participation in any other investigational drug study within 4 weeks
Use of certain drugs for cough management within 4 weeks: prednisone, opiates, baclofen, gabapentin, pregabalin, thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators
Use of ACE inhibitors or cromolyn sodium within 4 weeks
Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control during the study
History of hypersensitivity or intolerance to cromolyn sodium
Clareo Health | A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
