ReclutandoNCT06307665Registro de ClinicalTrials.gov

Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma

Asthma

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 3
Rango de edad: 12 años - 17 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 440 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.

Leer la descripción completa

This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks.

The study will consist of 3 periods:

1. Screening period (7 to 28 days)
2. Treatment period of 52 weeks
3. Safety follow-up period (7 to 14 days after the end of treatment \[EOT\] visit)

Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period.

This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Confirmed clinical diagnosis of asthma at least 12 months.
Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month

1. Low-to-high-dose Inhaled corticosteroid(s) (ICS)
2. Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline
* Receiving inhaled short-acting β2-agonist (SABA) as needed.
* A documented history of at least one severe asthma exacerbation within 12 months.
* Use of Sponsor-provided albuterol sulfate inhalation aerosol medication.
* Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited.
* Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator.
* Participants must adhere to protocol specific contraception methods.
* Negative urine pregnancy test for participants of childbearing potential.
* Have a BMI \< 40 kg/ m\^2.
* Capable of giving assent (signing the assent form) to participate in the study which includes compliance with the requirements and restrictions. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures.

Exclusion Criteria:

Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
Experienced \> 3 severe asthma exacerbations within 12 months before screening.
Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.
Upper respiratory infection involving antibiotic treatment not resolved.
Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana).
Other significant lung disease, including regular or occasional use of oxygen.
Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders.
Cancer not in complete remission for at least 5 years.
History or hospitalization for psychiatric disorder or attempted suicide within one year.
Significant abuse of alcohol or drugs, in the opinion of the investigator.
Oral corticosteroid(s) (OCS)/SCS use (any dose and any indication) within 4 weeks before Visit 1 or chronic use of OCS/SCS (≥ 3 weeks use in 3 months prior to Visit 1).
Use of any oral SABAs within one month.
Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento doble

Budesonide/albuterol metered -dose inhaler (BDA MDI)

Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed.

Combination Product: BDA MDI

Albuterol sulfate metered-dose inhaler (AS MDI)

Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed.

Combination Product: AS MDI

BDA MDI COMBINATION_PRODUCT

Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.

AS MDI COMBINATION_PRODUCT

Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Annualized rate of severe asthma exacerbations (AAER)

Plazo: From Randomization (Day 1) to Week 52 (EOT)

The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.

Medidas secundarias

Time to first (TTF) severe asthma exacerbation

Plazo: From Randomization (Day 1) to Week 52 (EOT)

The effect of BDA MDI compared with AS MDI, both administered as needed, on the risk of a first severe asthma exacerbation in participants with asthma will be evaluated.

Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma

Plazo: From Randomization (Day 1) to Week 52 (EOT)

The effect of BDA MDI compared with AS MDI, both administered as needed, on the annualized total SCS exposure for treatment of asthma in participants with asthma will be evaluated.

Number of participants with adverse events (AEs) and severe adverse events (SAEs)

Plazo: Up to Week 52

The safety and tolerability of BDA MDI compared with AS MDI in participants with asthma will be assessed.

Maximum Observed Concentration (Cmax)