Investigator Studies Program (MISP): Cough
Effective February 2021, the Cough Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest on a rolling basis. Reviews will occur monthly in 2021. This is a competitive process that will be conducted by the Cough MISP in 2021. Decisions will be made based on scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below. The program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.
The following areas are of interest to Investigator Studies Program Committee:
- Evaluation of “short and simple” validated PRO cough management/scoring tools in treatment of RCC and UCC
- To score patient feedback on (changes in) cough severity
- To score physician evaluation of change in cough severity
- To evaluate (changes in) impact on spouse, family, colleagues
- To evaluate impact of and on co-morbidities associated with CC
- Tools for measuring treatment success (improvement from baseline: what is the desired threshold of reduction from baseline)
- How best to measure treatment success? Which aspect of cough should be the best to monitor patients' response to treatment?
- A measure of "low" or "controlled" disease state.
- What level of improvement of cough frequency, severity and/or PRO improvements is needed for this "endpoint"?
- The availability of a cough control/scoring test for everyday clinical practice usage that takes little time to complete/evaluate?
- Cough severity status, QoL and – improvements should be associated with status and changes in scoring tool Tool should ideally be usable in telehealth consultation
- Studies in human tissues to evaluate pathophysiological mechanisms of RCC and UCC
- Characterization of ATP release from airway mucosal cells and/or C-fibers.
- Characterization of ATP release and c-fiber stimulation in patients with various reasons for CC (Asthma, NAEB, UACS, GERD. RCC, UCC, RCC)
- Are local reduction of ATP metabolism or increased P2X3/P2X2/3 receptor expression possible alternative mechanisms of RCC/UCC?
- Neurologic pathways and mechanisms involved in RCC and UCC, including neuroplasticity.
- Understanding of centrally mediated circuitry/control of the hypersensitized reflex arc that characterizes RCC/UCC (i.e. whether centrally mediated processes play a role in modulating RCC/UCC and the responsiveness, or lack thereof, to peripheral P2X3 inhibition).
- Characterization of biomarkers potentially associated with RCC/UCC.
- Pre-clinical mechanistic studies to investigate
- ATP release and its role in cough (i.e. cells that release ATP, factors that result in release, effects upstream from ATP release, other functions/effects of ATP release in airways).
- Potential mechanisms to further understand excessive ATP release vs hyper-response of ATP receptors.
- (Absence of) effect of P2X2, -2/3 and –3 inhibition on Aδ fibers and protective cough.
- The role of the P2X3, P2X2 and P2X2/3 receptor activation and inhibition in animal models of cough and taste.
Please complete a protocol with detailed budget via Visiontracker
, the Company's on-line study management system (in US). The proposals will be collectively reviewed and selected by the Cough MISP Committee.
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator
Studies Program should contact their local MSD office