Treatment of chronic cough with PA101

  • Research type

    Research Study

  • Full title

    Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in patients with Idiopathic Pulmonary Fibrosis (IPF) with PA101.

  • IRAS ID

    164557

  • Contact name

    Ahmet Tutuncu

  • Contact email

    atutuncu@patarapharma.com

  • Sponsor organisation

    Patara Pharma

  • Eudract number

    2014-004025-40

  • Duration of Study in the UK

    0 years, 6 months, 13 days

  • Research summary

    Cough serves a potentially beneficial purpose by clearing the airways. Chronic idiopathic cough is a cough lasting more than 8 weeks in adults with no identifiable cause (unexplained or idiopathic) and with no response to specific treatment. Another common cause of chronic cough is idiopathic pulmonary fibrosis (IPF), a progressive life-threatening disease characterized anatomically by scarring of the lungs and symptomatically by exertional dyspnea or shortness of breath.

    Inhaled cromolyn sodium is used as an anti-inflammatory agent and long-term treatment is reported to be safe and well tolerated. PA101 is a high concentration cromolyn sodium formulation for delivery via a high efficiency nebuliser. This study is being performed to assess the effectiveness, safety and tolerability of PA101 in patients with chronic cough: either as chronic idiopathic cough, or in patients with idiopathic pulmonary fibrosis.

    This study is designed as double-blind, placebo-controlled Phase 2 study to assess the effectiveness, safety and tolerability of 40mg PA101 for 14 days in patients with chronic cough as defined above. Eligible patients will be randomised at baseline to receive treatment with PA101 or placebo, three times daily for 14 days, before undergoing a washout period and then crossing over to the alternative treatment for 14 days.

    The total duration of participation for the individual patient will be approximately
    9 weeks, including a screening period within 14 days before the first treatment visit (day 1), two treatment periods of 14 days each, a wash-out period of 14 days between the treatments, and a safety follow-up phone call 7 (+/- 2 days) following the last study treatment.

    Study assessments during each treatment period will include assessment of 24-hour cough count, quality of life questionnaires, cough severity, pulmonary function tests, vital signs (blood pressure and heart rate), ECGs (heart trace), blood and urine tests.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    14/NW/1405

  • Date of REC Opinion

    10 Nov 2014

  • REC opinion

    Favourable Opinion