Chronic Cough
Additional Information
Why is the CALM-2 Study being done?
RCC is a cough persisting more than 8 weeks despite either adequate treatment of associated conditions, or when there is no identified cause despite appropriate clinical evaluation.1,2
RCC is thought to be caused by hypersensitization of the nerves controlling cough, leading to exaggerated cough from innocuous stimuli or in the absence of any stimuli.3 Patients with RCC often experience frequent and severe coughing, which can seriously impair their quality of life. Commonly reported consequences of frequent or severe coughing include stress, urinary incontinence, reduced quality of sleep, dysphonia, and exhaustion. It can also lead to social anxiety and isolation.4
Currently, there is noEuropean Medicines Agency (EMA) or US Food and Drug Administration (FDA)-approved treatment for RCC. Most medications used to manage coughing may cause undesirable side effects or stop working after some time.
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What will participation involve?
The CALM-2 Study will include approximately 675 patients and their participation could last up to 71 weeks (nearly 1.5 years). The study will involve up to 20 visits to the study center for assessments, and 2
phone calls. After screening, eligible patients will enter a blinded study treatment period, during which they will have periodic safety evaluations and cough frequency assessed using a cough monitor, and complete questionnaires about their health and cough in an electronic diary.
Participants will be randomized 1:1:1 to receive either 1 of 2 doses of BLU-5937 or a placebo during a 27-week blinded study treatment period. All participants will receive only the placebo at some point during the blinded study treatment period. Participants who complete the blinded study treatment period will enter a 28-week, open-label study treatment period, to receive 50 mg BLU-5937.