Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough (ASPIRE)

Overview

About this study

The purpose of this study is investigating the efficacy, safety, and tolerability of Taplucainium Inhalation Powder (NOC-110) once daily in adults with refractory or unexplained chronic cough.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Refractory or unexplained chronic cough for ≥ 12 months.
* Women of childbearing potential agree to follow the protocol specified contraceptive - guidance during the study.
* Males who are not vasectomized must agree to use the contraceptive methods defined in the protocol.
 * Able to provide Informed Consent.

Exclusion Criteria:

* Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds.
* Participants who are currently participating in another drug or device clinical study
* Participants who have participated in an Acute or Chronic Cough investigational study within 60 days before the start of the Screening.
* Current diagnosis of chronic obstructive pulmonary disease, bronchiectasis, unexplained pulmonary fibrosis, hemoptysis, bronchial asthma (not including resolved childhood asthma), or other pulmonary disease.
* Respiratory tract infection within 4 weeks of Screening.
* Any female who is pregnant or lactating or wishing to become pregnant.
* Donation of  > 1 Unit (450 milliliter or more) of blood within 90 days prior to the first dosing.
* Alcohol or drug use disorder within the past 2 years.
* Current smoker/vaper or individuals who have given up smoking within the past 6 months, and/or those with \>20 pack-year smoking history.
 * Current opiate/opioid use or medical history of opiate/opioid use disorder. History of concurrent malignancy or recurrence of malignancy in the last 2 years.
* Body Mass Index of ≥40 kg/m2.
* Positive results for human immunodeficiency virus, hepatitis B, or hepatitis C virus.
* Unable to refrain from the use of medications and treatments that can impact cough during the study.
* Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 09/13/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vivek Iyer, M.D., M.P.H.

Contact us for the latest status

Contact information:

Department of Medicine (DOM) Research Hub

(507) 266-1944

DOMRESEARCHHUB@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20581063

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