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A Study to Assess the Effectiveness and Safety of Taplucainium Inhalation Powder (NOC-110) in Adults with Refractory or Unexplained Chronic Cough
EU CTIS ID: 2024-515026-86-00
What this study is testing
To evaluate the effects of Taplucainium Inhalation Powder (NOC-110) once daily for 28 days at three dose levels: 1 mg, 3 mg, and 6 mg, versus Placebo on 24-hour cough frequency in Adults with Refractory or Unexplained Chronic Cough (rCC or uCC).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds.
- 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 (BMI) of ≥40 kg/m2
- Positive results for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus
- Unable to refrain from the use of medications and treatments that can impact cough during the study.
See the full eligibility 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
- Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds.
- 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 (BMI) of ≥40 kg/m2
- Positive results for human immunodeficiency virus (HIV), 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)
- 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 (COPD), 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 [mL] or more) of blood within 60 days prior to Screening.
- 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 of Screening, and/or those with >20 pack-year smoking history.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.