Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Foster 100/6 mg NEXThaler versus Foster 100/6 mg inhalador de dosis medida presurizado (pMDI) en pacientes con asma controlada. (FORTUNE)

24 de junio de 2026 actualizado por: Chiesi Farmaceutici S.p.A.

Un estudio de 12 semanas, multicéntrico, aleatorizado, doble ciego, con doble simulación, de grupos paralelos de 2 brazos que compara la eficacia y la seguridad de Foster 100/6 mg NEXThaler, 2 inhalaciones dos veces al día, versus Foster 100/6 mg pMDI, 2 inhalaciones dos veces al día en Pacientes con asma controlada

El propósito de este estudio es demostrar la no inferioridad de Foster 100/6 mg NEXThaler versus Foster 100/6 mg pMDI en términos de función pulmonar en pacientes asmáticos, así como el efecto de los tratamientos de prueba en términos de parámetros adicionales de función pulmonar y medidas de resultados clínicos. El propósito es también evaluar la seguridad y la tolerabilidad.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This was a phase III, multinational, multicentre, randomised, double-blind, double-dummy, active-control, 2-arm parallel group study designed to evaluate the non-inferiority of Foster® NEXThaler® 100/6 µg (400/24 µg/day) versus Foster® pMDI 100/6 µg (400/24 µg/day) in patients with controlled asthma.

The study included the following phases:

  • Pre-Screening Phase (Visit 0): Conducted within a maximum of 7 days before the screening visit (Visit 1), this phase provided patients with study details, obtained informed consent, and outlined medication restrictions.
  • Screening and Run-in Phase (Visit 1, Week -4 to Visit 2, Week -2): Patients underwent eligibility assessments and transitioned into a 4-week open-label run-in period with Foster® pMDI 100/6 µg (400/24 µg/day) to establish baseline parameters.
  • Randomisation Phase (Visit 3, Week 0): Eligible patients were randomised in a 1:1 ratio to receive either Foster® NEXThaler® 100/6 µg 2 inhalations bid (for a total daily dose of 400/24 µg/day) or Foster® pMDI 100/6 µg, 2 puffs bid (for a total daily dose of 400/24 µg/day) for 12 weeks. The allocation was managed via an Interactive Web Response System (IWRS) to ensure balanced treatment groups.
  • Investigational Phase (Treatment Period: Weeks 0-12): Patients attended scheduled visits at Weeks 2, 4, 6, 8, 10, and 12 to monitor efficacy and safety.

Daily, patients recorded pre-dose morning and evening Peak Expiratory Flow (PEF), rescue medication use, and asthma symptoms using an electronic peak flow meter and e-diary. At each visit, lung function (FEV1, FVC, and PEF), asthma symptom scores, and rescue medication use were assessed. Vital signs (heart rate, blood pressure) and safety outcomes (adverse events, serious adverse events, and laboratory assessments) were monitored.

  • Follow-Up Phase: A safety follow-up phone call was conducted 7-10 days after the final visit (Week 12) or early termination to assess any unresolved adverse events (AEs) or new concomitant medications.

The total study duration per participant was 16 weeks, including the 4-week run-in period, 12-week treatment phase, and 1-week follow-up. This design ensured a standardized baseline before randomisation and provided sufficient time to assess both primary and secondary endpoints.

Salbutamol (purchased locally and provided by the Investigator site to the patient) was used as a rescue medication.

Tipo de estudio

Intervencionista

Inscripción (Actual)

494

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana, 100144
        • Chiesi Clinical Trial site 15672
      • Beijing, Porcelana
        • Chiesi clinical Trial site 15636
      • Chongqing, Porcelana
        • Chiesi Clinical Trial site 15638
      • Guizhou, Porcelana
        • Chiesi Clinical Trial site 15670
      • Hebei, Porcelana
        • Chiesi clinical Trial Site 15611
      • Jilin City, Porcelana
        • Chiesi Clinical trial site 15660
      • Shanghai, Porcelana
        • Chiesi Clinical Trial site 15628
      • Shanghai, Porcelana
        • Chiesi clinical trial site 15637
      • Shenzhen, Porcelana
        • Chiesi Clinical Trial site 15666
      • Sichuan, Porcelana
        • Chiesi clinical Trial site 15633
      • Ürümqi, Porcelana, 830054
        • Chiesi Clinical Trial site 15669
    • Anhui
      • Hefei, Anhui, Porcelana
        • Chiesi Clinical Trial site 15641
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100000
        • Chiesi Clinical Trial site 15682
      • Beijing, Beijing Municipality, Porcelana, 101100
        • Chiesi Clinical Trial site 15663
    • Guangdong
      • Foshan, Guangdong, Porcelana
        • Chiesi Clinical Trial site 15662
      • Guangzhou, Guangdong, Porcelana, 5100150
        • Chiesi Clinical Trial site 15671
      • Guangzhou, Guangdong, Porcelana, 510120
        • Chiesi Clinical Trial site 15610
      • Guangzhou, Guangdong, Porcelana
        • Chiesi clinical Trial site 15656
      • Guangzhou, Guangdong, Porcelana
        • Chiesi Clinical Trial site 15668
      • Huizhou, Guangdong, Porcelana, 516001
        • Chiesi Clinical Trial site 15677
      • Shenzhen, Guangdong, Porcelana, 518052
        • Chiesi Clinical Trial site 15683
      • Shenzhen, Guangdong, Porcelana
        • Chiesi Clinical Trial site 15608
      • Zhanjiang, Guangdong, Porcelana, 524001
        • Chiesi Clinical Trial site 15607
    • Guangzhou
      • Guangzhou, Guangzhou, Porcelana, 511400
        • Chiesi Clinical Trial site 15610
    • Hainan
      • Haikou, Hainan, Porcelana, 570208
        • Chiesi Clinical Trial site 15673
    • Heilongjiang
      • Qiqihar, Heilongjiang, Porcelana, 161002
        • Chiesi Clinical Trial site 15678
    • Henan
      • Xinxiang, Henan, Porcelana, 453000
        • Chiesi Clinical Trial site 15681
      • Zhengzhou, Henan, Porcelana, 450003
        • Chiesi Clinical Trial site 15679
    • Hubei
      • Wuhan, Hubei, Porcelana, 430030
        • Chiesi Clinical Trial site 15614
      • Wuhan, Hubei, Porcelana
        • Chiesi Clinical Trial site 15661
    • Hunan
      • Hengyang, Hunan, Porcelana, 421000
        • Chiesi Clinical Trial site 15675
    • Jiangsu
      • Changzhou, Jiangsu, Porcelana, 213164
        • Chiesi Clinical Trial site 15643
    • Jiangxi
      • Pingxiang, Jiangxi, Porcelana, 337055
        • Chiesi Clinical Trial site 15674
    • Jilin
      • Jilin City, Jilin, Porcelana, 132011
        • Chiesi Clinical Trial site 15676
    • Liaoning
      • Shenyang, Liaoning, Porcelana
        • Chiesi clinical Trial site 15621
    • Nanchang
      • Nanchang, Nanchang, Porcelana, 330006
        • Chiesi clinical Trial site 15619
    • Neimenggu
      • Hohhot, Neimenggu, Porcelana, 010017
        • Chiesi Clinical Trial site 15650
      • Hohhot, Neimenggu, Porcelana
        • Chiesi clinical Trial site 15659
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200025
        • Chiesi Clinical Trial site 15630
      • Shanghai, Shanghai Municipality, Porcelana, 200050
        • Chiesi Clinical Trial site 15664
      • Shanghai, Shanghai Municipality, Porcelana, 201100
        • Chiesi Clinical Trial site 15654
      • Shanghai, Shanghai Municipality, Porcelana
        • Chiesi Clinical Trial site 15630
      • Shanghai, Shanghai Municipality, Porcelana
        • Chiesi Clinical Trial site 15631
      • Shanghai, Shanghai Municipality, Porcelana
        • Chiesi Clinical Trial site 15665
    • Shanxi
      • Taiyuan, Shanxi, Porcelana, 030001
        • Chiesi Clinical Trial site 15625
    • Shijiazhuang
      • Shijiazhuang, Shijiazhuang, Porcelana, 050000
        • Chiesi clinical Trial Site 15611
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610041
        • Chiesi clinical Trial site 15633
      • Chongqing, Sichuan, Porcelana, 408499
        • Chiesi Clinical Trial site 15680
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Porcelana, 300052
        • Chiesi Clinical Trial site 15642
      • Tianjin, Tianjin Municipality, Porcelana, 300350
        • Chiesi Clinical Trial site 15634
    • Xian
      • Xi'an, Xian, Porcelana, 710061
        • Chiesi Clinical Trial site 15626

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Pacientes ambulatorios masculinos o femeninos, etnia china mayores de 18 años con un diagnóstico clínico de asma durante un mínimo de 6 meses antes de la visita 1 confirmado por un neumólogo de acuerdo con las pautas internacionales actualizadas de 2016 Global Initiative Asthma (GINA).
  • Respuesta positiva a la prueba de reversibilidad.
  • FEV 1 (Volumen espiratorio forzado en el primer segundo) >80 % del valor normal predicho después del lavado adecuado de los broncodilatadores.
  • Pacientes con tratamiento regular anterior a una dosis estable durante al menos 3 meses antes de la visita 1 con una dosis diaria alta de ICS (corticosteroides inhalados) o una dosis diaria media de ICS

Criterio de exclusión:

  • Mujeres embarazadas o lactantes
  • Asma intermitente o asma que ocurre solo durante la exposición episódica a un alérgeno o un sensibilizador químico
  • Diagnóstico de enfermedad pulmonar obstructiva crónica (EPOC) según la definición de las directrices actuales de la Iniciativa Glocal para la enfermedad pulmonar obstructiva crónica (GOLD) actualizadas en 2016
  • Fumadores actuales o ex fumadores
  • Exacerbación de asma grave que conduce a la ingesta de corticosteroides sistémicos (> 10 días) en el mes anterior a la inclusión o exacerbaciones de asma moderadas/graves
  • Pacientes tratados con anticuerpos monoclonales
  • Pacientes tratados con diuréticos no ahorradores de potasio
  • Pacientes tratados con inhibidores de la monoaminooxidasa y antidepresivos tricíclicos
  • Pacientes que están recibiendo terapia que podría interactuar con los esteroides

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Foster 100/6µg NEXThaler

Patients in this arm received Foster® NEXThaler® 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI).

Treatment Details:

  • Dosage: 2 inhalations twice daily (b.i.d.), totaling 400/24 µg BDP/FF daily.
  • Duration: 12 weeks.
  • Administration: First dose under medical supervision at randomization (Week 0).

Blinding & Control Treatment:

  • A double-dummy design was used. Patients also received a placebo pMDI (matching active pMDI), administered as 2 puffs b.i.d. to maintain blinding.

Background Therapy:

  • Salbutamol was provided as rescue medication.

Patient Training & Compliance:

  • Inhaler use was assessed at visits, with retraining as needed; patients used an AeroChamber Plus™ spacer if necessary, and each inhaler was labeled with "sun" (morning) and "moon" (evening) stickers.
Droga: Foster 100/6µg NEXThaler
A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI).
Otros nombres:
  • beclometasone dipropionate (BDP) 100 µg / formoterol fumarate (FF) 6 µg NEXThealer
Comparador activo: Foster 100/6µg pMDI

Patients in this arm received Foster® pMDI 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI).

Treatment Details:

  • Dosage: 2 puffs twice daily (b.i.d.), totaling 400/24 µg BDP/FF daily.
  • Duration: 12 weeks.
  • Administration: First dose under medical supervision at randomization (Week 0).

Blinding & Control Treatment:

  • A double-dummy design was used. Patients also received a placebo DPI (matching active DPI), administered as 2 inhalations b.i.d. to maintain blinding.

Background Therapy:

  • Salbutamol was provided as rescue medication.

Patient Training & Compliance:

  • Inhaler use was assessed at visits, with retraining as needed; patients used an AeroChamber Plus™ spacer if necessary, and each inhaler was labeled with "sun" (morning) and "moon" (evening) stickers.
Droga: Foster 100/6µg pMDI
A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI) with HFA_134a propellant.
Otros nombres:
  • beclometasone dipropionate (BDP) 100µg / formoterol fumarate (FF) 6µg pMDI

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline to End of Treatment Period in Average Pre-dose Morning Peak Expiratory Flow (PEF)
Periodo de tiempo: Baseline (Week 0, Visit 3) and Week 12 (EoT)

PEF= peak expiratory flow. The peak expiratory flow (also known as a peak flow or peak flow rate) is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration.

In this study PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.

  • Baseline pre-dose morning PEF was calculated as the mean of all valid pre-dose morning Best PEF values from the last 14 days before randomization (Week 0, Visit 3).

  • The average pre-dose morning PEF over the entire treatment period was computed as:

    ∑Valid pre-dose morning Best PEF values (treatment period) / Number of days with available data

  • Valid pre-dose morning Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min
Baseline (Week 0, Visit 3) and Week 12 (EoT)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline to Each 2-week (Inter-visit) Treatment Period in Average Pre-dose Morning Peek Expiratory Flow (PEF)
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)

PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: in the morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.

  • Baseline pre-dose morning PEF was calculated as the mean of all valid pre-dose morning Best PEF values from the last 14 days before randomization (Week 0, Visit 3).

  • The average pre-dose morning PEF for each inter-visit period was computed as:

    ∑all valid pre-dose morning Best PEF values / number of days with available data

  • Valid pre-dose morning Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Pre-dose Evening PEF
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks.

PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.

  • Baseline pre-dose evening PEF was calculated as the mean of all valid pre-dose evening Best PEF values from the last 14 days before randomization (Week 0, Visit 3).

  • The average pre-dose evening PEF for each inter-visit period was computed as:

    ∑all valid pre-dose evening Best PEF values / number of days with available data

  • Valid pre-dose evening Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks.
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Daily PEF Variability
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.

  • Baseline average daily PEF variability was calculated as the mean of all daily PEF variability values recorded in the last 14 days before randomization (Week 0, Visit 3).

  • The average daily PEF variability for each inter-visit period was computed as:

    ∑all daily PEF variability values / number of days with available data

  • Daily PEF variability was calculated only for days where both pre-dose morning Best PEF and pre-dose evening Best PEF values were available.
  • Valid Best PEF values were defined as the highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Use of Rescue Medication (Number of Puffs/Day)
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning.

  • Baseline rescue medication use was the mean daily use over the last 14 days before randomization (Week 0, Visit 3).

  • Average daily use of rescue medication was calculated as:

    • all puffs per day / number of days with available data
  • It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the entire treatment period (from the evening of the first treatment day to the morning of the last).
  • At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Rescue Medication-Free Days
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning.

  • Baseline percentage of rescue medication-free days was calculated over the last 14 days before randomization (Week 0, Visit 3).
  • Percentage of rescue medication-free days was calculated as:

(Number of days with no rescue medication use / Total number of days with available data)×100

  • It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the entire treatment period (from the evening of the first treatment day to the morning of the last).
  • At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Total Morning Asthma Symptom Score
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows:

Daytime asthma symptom score (ranging 0-3, where the lower the score the better the outcome):

0 No symptom

  1. Mild: symptoms not causing awakening
  2. Moderate: discomfort causing awakenings
  3. Severe: causing awakenings for most of the night / don't allow to sleep at all The average score of each symptom is the mean value of all measurements (recorded in the evening session, as per study methodology).

Total average Daily Asthma Symptoms score daytime = Σ(Cough daytime score + Wheeze daytime score + Chest Tightness daytime score + Breathlessness daytime score)/ Number of days with available data.

The average of daytime asthma symptoms is the mean value of all daytime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Total Evening Asthma Symptom Scores
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows:

Nighttime asthma symptom score (ranging 0-3, where the lower the score the better the outcome):

0 No symptom

  1. Mild: symptoms not causing awakening
  2. Moderate: discomfort causing awakenings
  3. Severe: causing awakenings for most of the night / don't allow to sleep at all The average score of each symptom is the mean value of all measurements (Recorded in the morning session of the next day).

Total average Daily Asthma Symptoms score nighttime = Σ(Cough nighttime score + Wheeze nighttime score + Chest Tightness nighttime score + Breathlessness nighttime score)/ Number of days with available data.

The average of nighttime asthma symptoms is the mean value of all nighttime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Asthma Symptom-Free Days
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

An asthma symptom-free day was defined as a day with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included.

  • Baseline percentage of symptom-free days was the mean percentage over the last 14 days before randomization (Week 0, Visit 3).
  • Percentage of asthma symptom-free days was calculated as:

(Number of symptom-free days / Total number of days with available data)×100

  • It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the 12-week treatment period (from the evening of treatment start to the morning of treatment end).
  • At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Asthma Control Days
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

An asthma control day was defined as a day without rescue medication use and with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included in the calculation.

  • Baseline percentage of asthma control days was the mean percentage over the last 14 days before randomization (Week 0, Visit 3).
  • Percentage of asthma control days was calculated as:

(Number of asthma control days / Total number of days with available data)×100

  • It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the 12-week treatment period (from the evening of treatment start to the morning of treatment end).
  • At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline in Pre-Dose Morning FEV1 at Each Clinic Visit
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)

Forced Expiratory Volume in 1 second (FEV1) was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FEV1 was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12).

Patients performed spirometry in a seated position, using the same calibrated spirometer across all visits. They inhaled deeply to total lung capacity and exhaled forcefully and completely. At least three acceptable maneuvers were required, with the highest valid measurement recorded. FEV1 was expressed in liters (L), and a higher value indicated better lung function.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
Change From Baseline in Pre-Dose Morning FVC at Each Clinic Visit
Periodo de tiempo: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)

Forced vital capacity (FVC) is the maximum capacity of air that a patient can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. FVC was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FVC was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12).

Patients performed spirometry in a seated position, ensuring consistency across visits. They were instructed to inhale deeply to full lung capacity and exhale forcefully and completely into the spirometer. At least three acceptable maneuvers were required per session, with the highest valid measurement recorded. The higher the capacity, measured in liters, the better the outcome.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
Change From Baseline to Last Visit in ACQ-6 Score
Periodo de tiempo: Week 12 (Visit 9, End of Treatment - EOT)

The ACQ-6 was a validated questionnaire assessing asthma control, consisting of six items: five on asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and one on rescue medication use, all self-administered. Each item was scored from 0 (no impairment) to 6 (maximum impairment), and the ACQ-6 total score was the mean of all six items, ranging from 0 (totally controlled asthma) to 6 (severely uncontrolled asthma). Hence, the higher the score, the worse the outcome.

Baseline ACQ-6 was assessed at Visit 3 (Week 0, randomization), and the final score was recorded at Visit 9 (Week 12, EOT). The change from baseline was calculated as the difference between these values .
Week 12 (Visit 9, End of Treatment - EOT)
Number of Participants With at Least One Adverse Event (TEAE) or Adverse Drug Reaction (ADR)
Periodo de tiempo: From Week 0 (Visit 3, Randomization) to Week 12 (Visit 9, EoT)

An adverse event (AE) was defined as "any untoward medical occurrence in a patient or clinical study patient administered a medicinal product and which did not necessarily have a causal relationship with this treatment". An AE could therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

An adverse drug reaction (ADR) was defined as an "untoward and unintended response to an investigational medicinal product related to any dose administered".

An SAE/serious ADR was defined as any untoward medical occurrence or effect that at any dose Resulted in death, Was life-threatening, Required hospitalisation or prolongation of existing hospitalisation, Resulted in persistent or significant disability or incapacity, Was a congenital anomaly or birth defect, Was a medically significant AE.
From Week 0 (Visit 3, Randomization) to Week 12 (Visit 9, EoT)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Chiesi Farmaceutici S.p.A.

Investigadores

  • Investigador principal: Jinping MD Zheng, The First Affiliated Hospital of Guangzhou Medical University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de octubre de 2017

Finalización primaria (Actual)

28 de diciembre de 2021

Finalización del estudio (Actual)

28 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

12 de febrero de 2018

Primero enviado que cumplió con los criterios de control de calidad

26 de febrero de 2018

Publicado por primera vez (Actual)

5 de marzo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CCD-01535BA0-01
  • CTR20170917 (Otro identificador: http://www.chinadrugtrials.org.cn/)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir