Clinical trial NCT06504446: Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults with Refractory or Unexplained Chronic Cough
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Taplucainium Inhalation Powder (NOC-110) in Adults with Refractory or Unexplained Chronic Cough
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Refractory or Unexplained Chronic Cough
Lead sponsor: Nocion Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2024-07-16
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in 24-hour Coughs per hour from Baseline
timeFrame: Baseline to End of Treatment
Secondary outcomes:
measure: Change in Awake coughs per hour from Baseline
timeFrame: Baseline to End of Treatment
measure: Change in the Cough Severity Visual Analog Scale from Baseline
timeFrame: Baseline to End of Treatment
measure: Change in the Urge to Cough Visual Analog Scale from Baseline
timeFrame: Baseline to End of Treatment
measure: Change in the Leicester Cough Questionnaire from Baseline
timeFrame: Baseline to End of Treatment
measure: Patient Global Impressions of Improvement score
timeFrame: End of Treatment
measure: Incidence and severity of adverse events and serious adverse events
timeFrame: Baseline to End of Treatment
Other outcomes:
Locations:
city: Foley
country: United States
facility: G & L Research, LLC
state: Alabama
city: Tempe
country: United States
facility: AMR Phoenix
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma, P.A. Clinical Research Center
state: Arkansas
city: Laguna Niguel
country: United States
facility: Allergy and Asthma Associates of Southern California dba Southern California Research
state: California
city: Newport Beach
country: United States
facility: NewportNativeMD,Inc
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Centers, LLC
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley
state: California
city: San Jose
country: United States
facility: California Allergy & Asthma Medical Group Inc.
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research Inc
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Debary
country: United States
facility: Omega Research Debary, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Leesburg
country: United States
facility: Clinical Site Partners, LLC Leesburg dba Flourish Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corporation
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC Orlando dba Flourish Research
state: Florida
city: Winfield
country: United States
facility: Duly Health and Care
state: Illinois
city: Ames
country: United States
facility: Accellacare of McFarland Clinic
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic, PC
state: Iowa
city: Lexington
country: United States
facility: Bluegrass Allergy Research
state: Kentucky
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists, PSC
state: Kentucky
city: Towson
country: United States
facility: Continental Clinical Solutions, LLC
state: Maryland
city: Dartmouth
country: United States
facility: Infinity Medical Research Inc
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: St. Charles
country: United States
facility: Midwest Chest Consultants
state: Missouri
city: St. Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: St. Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: Las Vegas
country: United States
facility: AMR Las Vegas
state: Nevada
city: Ocean
country: United States
facility: Allergy Partners of New Jersey P C
state: New Jersey
city: Asheville
country: United States
facility: Allergy Partners Clinical Research
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Winston Salem
country: United States
facility: Southeastern Research Center LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare
state: North Carolina
city: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Warwick
country: United States
facility: Care Access Research - Warwick 1
state: Rhode Island
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care, P.A.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Accellacare
state: South Carolina
city: North Charleston
country: United States
facility: National Allergy and Asthma Research, LLC
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol, PC
state: Tennessee
city: Knoxville
country: United States
facility: Accellacare d/b/a Accellacare of Knoxville
state: Tennessee
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting, Inc.
state: Texas
city: San Antonio
country: United States
facility: South Texas Allergy & Asthma Medical Professionals
state: Texas
city: San Antonio
country: United States
facility: Alamo ENT Associates
state: Texas
city: Williamsburg
country: United States
facility: TPMG Clinical Research Williamsburg
state: Virginia
city: Greenfield
country: United States
facility: Allergy, Asthma & Sinus Center, SC
state: Wisconsin
city: Leuven
country: Belgium
facility: UZ Leuven
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Namur
country: Belgium
facility: Pneumocare
city: Roeselare
country: Belgium
facility: AZ Delta
city: Ajex
country: Canada
facility: Dynamic Drug Advancement
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: Inspiration Research Limited
state: Ontario
city: Montréal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Québec
country: Canada
facility: Clinique Specialisee en Allergie de la Capitale
state: Quebec
city: Saint-Charles-Borromee
country: Canada
facility: Clinique de pneumologie et du sommeil de Lanaudière
state: Quebec
city: Sherbrooke
country: Canada
facility: DIEX Recherche Sherbrooke Inc.
state: Quebec
city: Victoriaville
country: Canada
facility: DIEX Recherche Victoriaville Inc.
state: Quebec
city: Quebec
country: Canada
facility: DIEX Recherche Quebec Inc.
city: Muenchen
country: Germany
facility: Pneumologisches Studienzentrum Muenchen West
state: Bayern
city: Darmstadt
country: Germany
facility: Lungenzentrum Darmstadt
state: Hessen
city: Frankfurt
country: Germany
facility: Medaimun GmbH
state: Hessen
city: Marburg
country: Germany
facility: Zentrum fuer ambulante pneumologische Forschung Marburg GbR
state: Hessen
city: Halle
country: Germany
facility: Pneumologicum Halle
state: Sachsen Anhalt
city: Geesthacht
country: Germany
facility: Pneumologisches Forschungsinstitut Hohegeest GbR
state: Schleswig Holstein
city: Berlin
country: Germany
facility: Pneumologisches Studienzentrum MVZ "Die Lungenärzte"
city: Bialystok
country: Poland
facility: Prywatny Gabinet Internistyczno-Alergologiczny
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz
city: Częstochowa
country: Poland
facility: Centrum Medyczne Pratia Czestochowa
city: Ostrowiec Swietokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
city: Strzelce Opolskie
country: Poland
facility: Centrum Medyczne Lucyna Andrzej Dymek s.c.
city: Szczecin
country: Poland
facility: Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Dorota Maria Małosek
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O.
city: Belfast
country: United Kingdom
facility: Ormeau Clinical Trials Ltd
city: Bristol
country: United Kingdom
facility: West Walk Surgery
Study officials:
affiliation: Chief Medical Officer Nocion Therapeutics, Inc.
name: Bernard L Silverman, MD
role: STUDY_DIRECTOR
References: