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

Nocion Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Refractory or Unexplained Chronic Cough

Treatments: Drug: NOC-110; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06504446

NOC110-C-202

Details and patient eligibility

About

This is a phase 2b, randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of Taplucainium Inhalation Powder (NOC-110) once daily in adults with refractory or unexplained chronic cough.

Full description

Approximately 325 participants will take part in the study. It is anticipated that up to 600 participants will be screened. Participation will be approximately 13 weeks.

Enrollment: 325 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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, or other pulmonary disease.
• Respiratory tract infection within 4 weeks of Screening or during screening period.
• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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325 participants in 4 patient groups, including a placebo group

NOC-110 1mg

Experimental group

Description:

NOC-110 (taplucainium) administered by daily dry powder inhalation. NOC-110 contains a dry powder lactose blend containing drug substance taplucainium administered using an available inhaler.

Treatment:

Drug: NOC-110

NOC-110 3mg

Experimental group

Description:

NOC-110 (taplucainium) administered by daily dry powder inhalation. NOC-110 contains a dry powder lactose blend containing drug substance taplucainium administered using an available inhaler.

Treatment:

Drug: NOC-110

NOC-110 6mg

Experimental group

Description:

NOC-110 (taplucainium) administered by daily dry powder inhalation. NOC-110 contains a dry powder lactose blend containing drug substance taplucainium administered using an available inhaler.

Treatment:

Drug: NOC-110

Placebo

Placebo Comparator group

Description:

The matching placebo contains inhalation grade lactose blended with arginine. The blend is taste masked to the active drug product to minimize unblinding due to taste differences. The matching placebo will be administered via the same inhaler.

Treatment:

Other: Placebo