Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- 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.
- 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.