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    Summary
    EudraCT Number:2014-004025-40
    Sponsor's Protocol Code Number:PA101-CC-02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004025-40
    A.3Full title of the trial
    Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in patients with Idiopathic Pulmonary Fibrosis (IPF) with PA101.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of chronic cough with PA101.
    A.3.2Name or abbreviated title of the trial where available
    Treatment of chronic cough with PA101
    A.4.1Sponsor's protocol code numberPA101-CC-02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPatara Pharma
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPatara Pharma
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAhmet Tutuncu
    B.5.2Functional name of contact pointChief Mecical Officer
    B.5.3 Address:
    B.5.3.1Street Address11455 El Camino Real, Suite 460
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+10018584361627
    B.5.6E-mailatutuncu@patarapharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDisodium Cromoglycate [cromolyn sodium]
    D.3.2Product code PA101
    D.3.4Pharmaceutical form Nebulisation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 15826-37-6
    D.3.9.2Current sponsor codePA101
    D.3.9.3Other descriptive nameDisodium cromoglycate (DSCG)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNebulisation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Idiopathic Cough and Chronic Cough in Idiopathic Pulmonary Fibrosis
    E.1.1.1Medical condition in easily understood language
    Chronic Cough
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10066656
    E.1.2Term Chronic cough
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether PA101 (inhaled cromolyn sodium) is an effective treatment for chronic cough when inhaled through a high efficiency nebuliser.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of PA101 (inhaled cromolyn sodium) in patients with chronic cough.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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
    E.5.1.1Timepoint(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.
    E.5.2Secondary 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)
    E.5.2.1Timepoint(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).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There is no provision of continued care and study medication will not be available to patients after the study. Patients will return to standard care following study completion.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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