Resumen

The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.

Descripción detallada

The study will include a screening period to determine participant inclusion, and the Baseline visit will include 24 hours of objective measurement of cough. The study will consist of two treatment periods, a main 12-week treatment period and a 40-week extension period (52 weeks total treatment), followed by a 14-day telephone follow-up period. Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 3-month, Off-treatment Durability Study Period, which extends the Estimated Study Completion Date. The Off-treatment Durability Study Period will explore the impact of withdrawing gefapixant in refractory or unexplained chronic cough participants who have been treated for 1 year.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
Female participants are eligible if not pregnant, not breastfeeding, and either not of childbearing potential, or agree to follow contraceptive guidance
Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Criterios de exclusión

Is a current smoker or has given up smoking within 12 months of Screening
Has forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio \<60%
Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
Has a history of chronic bronchitis
Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
Has an estimated glomerular filtration rate (eGFR) \<30mL/min/1.73 m\^2 at Screening OR eGFR ≥30 mL/min/1.73 m\^2 and \<50 mL/min/1.73 m\^2 at Screening with unstable renal function
Has a history of malignancy \<=5 years
Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
Has systolic blood pressure \>160 mm Hg or diastolic blood pressure \>90 mm Hg at Screening
Has a known allergy/sensitivity or contraindication to gefapixant
Has donated or lost \>=1 unit of blood within 8 weeks prior to the first dose of gefapixant
Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study
Had significantly abnormal laboratory tests at Screening

Intervenciones

drug

Placebo

Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.

drug

Gefapixant

Gefapixant 15 mg or 45 mg tablet administered orally BID during the 12-week main study period and during the 40-week extension period, according to randomization.

Ubicaciones

InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)

Caba, Buenos Aires, Argentina

Fundacion CIDEA ( Site 0323)

Ciudad de Buenos Aires, Buenos Aires, Argentina

Instituto Ave Pulmo ( Site 0322)

Mar del Plata, Buenos Aires, Argentina

Centro Medico Privado de Reumatologia ( Site 0309)

San Miguel de Tucumán, Tucumán Province, Argentina

Investigaciones en Patologias Respiratorias ( Site 0325)

San Miguel de Tucumán, Tucumán Province, Argentina

CEMEDIC - Centro de Especialidades Medicas ( Site 0304)

Buenos Aires, Argentina

Centro Medico Dra De Salvo ( Site 0310)