This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.

Elegibilidad

Edad mínima: 4 YearsSexo: ALL

Criterios de inclusión

Female or male aged ≥4 years at the time of informed consent
Physician diagnosis of asthma documented for at least 1 year
Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1:
Medium-to-high-dose inhaled corticosteroid (ICS)
Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline
Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist (LABA) with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophylline
Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to \<90% predicted normal value for adults and adolescents, and ≥60 to \<100% predicted normal value for subjects aged 4 to 11 years after withholding specified medications including short/rapid-acting β2-adrenoreceptor agonist (SABA)
Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for subjects aged ≥18 years) relative to baseline after administration of sponsor provided Ventolin via central spirometry. One re-test for reversibility testing is allowed within the screening period in advance of Visit 2
Demonstrate acceptable spirometry performance (i.e., meet American Thoracic Society/European Respiratory Society acceptability/repeatability criteria)
A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1
Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator

Criterios de exclusión

Chronic obstructive pulmonary disease or other significant lung disease (e.g., chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit 1
Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)
Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or any other prohibited medication
Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months before Visit 1 (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana)
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) within 5 years of Visit 1
Historical or current evidence of a clinically significant disease
Cancer not in complete remission for at least 5 years
Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
Significant abuse of alcohol or drugs

Intervenciones

combination_product

Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg

Budesonide/albuterol sulfate combination inhalation aerosol

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Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg

Budesonide/albuterol sulfate combination inhalation aerosol

drug

Albuterol sulfate metered-dose inhaler 180 μg

Albuterol sulfate inhalation aerosol

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

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Córdoba, Argentina

Research Site

Lanús, Argentina

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Mar del Plata, Argentina

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Mendoza, Argentina

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Mendoza, Argentina

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Quilmes, Argentina

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Rosario, Argentina

Research Site

Rosario, Argentina

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Rosario, Argentina

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Salta, Argentina

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San Fernando, Argentina

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San Juan Bautista, Argentina

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San Miguel de Tucumán, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

Santa Fe, Argentina

Research Site

Santa Fe, Argentina

A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg

Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg

Albuterol sulfate metered-dose inhaler 180 μg

Ubicaciones

Research Site

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Patrocinadores