Chronic Idiopathic Cough and Chronic Cough in Idiopathic Pulmonary Fibrosis MedDRA version: 18.0 Level: LLT Classification code 10066656 Term: Chronic cough System Organ Class: 100000004855
Conditions
Interventions
Product Name: Disodium Cromoglycate [cromolyn sodium]
Product Code: PA101
Pharmaceutical Form: Nebulisation solution
INN or Proposed INN: Not available
CAS Number: 15826-37-6
Current Sponsor code: PA1
Sponsors
Patara Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: COHORT 1: IDIOPATHIC PULMONARY FIBROSIS (IPF) 1. Male or female patients age 40 through 79 years, inclusive 2. Diagnosis of Idiopathic Pulmonary Fibrosis with the consensus of the multidisciplinary team based on the presence of definitive or possible usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) and after excluding alternative diagnoses, including lung diseases associated with environmental and occupational exposure, with connective tissue diseases and with drugs 3. Chronic cough present for at least 8 weeks and not responsive to current therapies 4. Daytime cough severity score on visual analogue scale > 40 mm at the Screening Visit 5. Daytime average cough count of at least 15 coughs per hour using objective cough count monitor at the Screening Visit 6. Transfer capacity for carbon monoxide corrected for hemoglobin (TLCOc) > 25% predicted value within 12 months of the Screening Visit and Forced Vital Capacity (FVC) > 50% predicted value within 1 month of the Screening Visit 7. Willingness and ability to provide written informed consent COHORT 2: CHRONIC IDIOPATHIC COUGH (CIC) 1. Male or female patients age 18 through 75 years, inclusive 2. Chronic cough that has been present for at least 8 weeks 3. Diagnosis of chronic idiopathic cough (CIC) that is unresponsive to targeted treatment for identified underlying triggers (i.e., post-nasal drip, asthmatic/non-asthmatic eosinophilic bronchitis, and gastro-esophageal reflux disease) 4. Cough score on visual analogue scale of > 40 mm at the Screening Visit 5. Daytime average cough count of at least 15 coughs per hour using objective cough count monitor at the Screening Visit 6. Willingness and ability to provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: COHORT 1: IPF 1. Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could put the patient 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 3 months of the Screening Visit 5. Long-term daily oxygen therapy (>10 hours/day) 6. Presence of pulmonary arterial hypertension with limitation of activity 7. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma or cervix carcinoma in situ 8. Current or recent history (previous 12 months) of excessive use or abuse of alcohol 9. Current or recent history (previous 12 months) of abusing legal drugs or use of illegal drugs or substances 10. Participation in any other investigational drug study within 4 weeks prior to the Screening Visit 11. Use of the following drugs within 2 weeks of the Screening Visit: Prednisone, narcotic antitussives, baclofen, gabapentin, inhaled corticosteroids, benzonatate, dextromethorphan, carbetapentane, H1 antihistamines, leukotriene modifiers, and cromolyn sodium 12. Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study (e.g., abstinence, combination barrier and spermicide, or hormonal) 13. History of hypersensitivity or intolerance to cromolyn sodium COHORT 2: CHRONIC IDIOPATHIC COUGH (CIC) 1. Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could put the patient at risk or compromise the quality of the study data as determined by the investigator 2. An upper or lower respiratory tract infection within 4 weeks of the Screening Visit 3. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma or cervix carcinoma in situ 4. Current or recent history (previous 12 months) of excessive use or abuse of alcohol 5. Current or recent history (previous 12 months) of abusing legal drugs or use of illegal drugs or substances 6. Participation in any other investigational drug study within 4 weeks prior to the Screening Visit 7. Use of the following drugs within 2 weeks of the Screening Visit: Prednisone, narcotic antitussives, baclofen, gabapentin, inhaled corticosteroids, benzonatate, dextromethorphan, carbetapentane, H1 antihistamines, leukotriene modifiers, and cromolyn sodium 8. Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study (e.g., abstinence, combination barrier and spermicide, or hormonal) 9. History of hypersensitivity or intolerance to cromolyn sodium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the safety and tolerability of PA101 (inhaled cromolyn sodium) in patients with chronic cough.;Main Objective: To assess whether PA101 (inhaled cromolyn sodium) is an effective treatment for chronic cough when inhaled through a high efficiency nebuliser.;Primary end point(s): Efficacy: • Change from baseline in daytime average cough count measured by LCM • Change from baseline in 24-hour average cough count measured by LCM • Change from baseline in the LCQ score • Change from baseline in quality of life as measured by K-BILD score (IPF cohort only) • Change from baseline in cough severity as measured by VAS score • Change from baseline in PFTs (IPF cohort only) • Change from baseline in FeNO as measured by Niox Vero ;Timepoint(s) of evaluation of this end point: Objective cough counts measured by LCM will be measured at Day 1 and Day 15 of each treatment visit. Monitors being applied 24 hours prior. FeNO, VAS, LCQ, K-BILD (IPF patients only) scores will be measured on Day 1, Day 7 and Day 15 of each treatment period. PFTs (in IPF cohort only) will be measured on Day 1 and Day 15 of each treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: • Adverse events • Change in vital signs (i.e., blood pressure and heart rate) • Change in 12-lead ECG • Clinical laboratory tests (i.e., hematology, biochemistry, urinalysis) ;Timepoint(s) of evaluation of this end point: Adverse events will be monitored from the first day of treatment (Day 1) and reviewed at each treatment visit (Day 7, Day 14 and Day 15) and during the follow-up safety call. Vital signs and ECG will be tested at screening and repeated on Day 1, Day 7 and Day 15 of each treatment period. Clinical laboratory tests will be tested at screening and repeated during treatment period 1 (Day 15) and treatment visit 2 (Day 1 and Day 15). | — |
Countries
Netherlands, United Kingdom
Contacts
Public ContactChief Mecical Officer
Ahmet Tutuncu
Outcome results
None listed