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

TRIPLE EN ASMA CON PACIENTES NO CONTROLADOS CON FUERZA MEDIA DE ICS + LABA (TRIMARAN)

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

UN ENSAYO DE 52 SEMANAS, ALEATORIZADO, DOBLE CIEGO, MULTINACIONAL, MULTICÉNTRICO, CON CONTROL ACTIVO, DE 2 BRAZOS DE GRUPOS PARALELOS QUE COMPARÓ CHF 5993 100/6/12,5 µg pMDI (COMBINACIÓN FIJA DE DIPROPIONATO DE BECLOMETASONA EXTRAFINA MÁS FORMOTEROL FUMARATO MÁS BROMURO DE GLICOPIRRONIO)35 CHF 1005 /6 µg pMDI (COMBINACIÓN FIJA DE DIPROPIONATO DE BECLOMETASONA EXTRAFINA MÁS FUMARATO DE FORMOTEROL) EN PACIENTES CON ASMA NO CONTROLADA CON DOSIS MEDIA DE CORTICOSTEROIDES INHALADOS EN COMBINACIÓN CON AGONISTAS ß2 DE ACCIÓN PROLONGADA

El propósito de este estudio es evaluar la superioridad de CHF 5993 100/6/12.5 µg pMDI (combinación fija de dipropionato de beclometasona extrafina más fumarato de formoterol más bromuro de glicopirrono) versus CHF 1535 100/6 µg pMDI (combinación fija de dipropionato de beclometasona extrafina más fumarato de formoterol), en términos de parámetros de función pulmonar y tasa de exacerbaciones, así como para evaluar su seguridad y algunos resultados económicos de la salud.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and following all other requirements of local laws.

From screening to the end of treatment, vital signs were recorded pre-dose at screening and pre- and postdose at all visits during the treatment period; physical examination was performed at all visits; concomitant medications and adverse events (AEs) were recorded, and asthma exacerbations were assessed at all visits; lung function tests were performed (pre-dose for forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) from screening to end of treatment visits, pre-dose for inspiratory capacity and vital capacity and postdose serial spirometry at all visits during the treatment period).

Patients completed the electronic diary from home twice daily from the time of screening until the end of treatment, to record asthma symptoms, treatment compliance, and use of rescue medication. Patients used the electronic peak flowmeter to record peak expiratory flow twice daily from home from the time of screening until the end of treatment.

Asthma Control Questionnaire© (ACQ)-7 was completed at screening and all visits during the treatment period. The EuroQuality of Life-5-Dimensional-3-Level questionnaire, and health economic and outcome assessments were competed at all visits during the treatment period.

Rescue medication (salbutamol 100 μg per inhalation) was permitted throughout the treatment period when absolutely needed; the maximum allowed dose was 8 inhalations/day (800 μg).

An independent Data Safety Monitoring Board was established to provide impartial safety evaluation and assurance for patients.

Tipo de estudio

Intervencionista

Inscripción (Actual)

1155

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

  • Alemania
      • Rostock, Alemania
        • Chiesi Clinical Trial Site 276814

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 a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Historia de asma ≥ 1 año y diagnosticada antes de los 40 años
  • Asma no controlada con terapia doble solo con dosis medias de corticoesteroide inhalado (ICS) en combinación con agonista beta2 de acción prolongada (LABA) con ACQ-7 (Cuestionario de control del asma) ≥1.5
  • FEV1 pre-broncodilatador <80% del valor normal predicho
  • Prueba de reversibilidad positiva
  • Al menos 1 exacerbación de asma documentada en el año anterior

Criterio de exclusión:

  • Mujeres embarazadas o lactantes
  • Diagnóstico de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)
  • Pacientes con cualquier exacerbación del asma o infección del tracto respiratorio en las 4 semanas previas a la selección
  • Fumadores actuales o exfumadores (>= 10 paquetes año)
  • Cualquier cambio en la dosis, programa o formulación de la combinación de ICS + LABA en las 4 semanas previas a la selección

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: CHF 5993 100/6/12.5 µg

CHF 5993 100/6/12.5

CHF 5993 100/6/12.5 µg: 2 inhalations bid Total daily dose: 400/24/50 µg BDP/FF/GB

BDP=Beclometasone Dipropionate bid=Twice daily FF=Formoterol Fumarate GB=Glycopyrronium Bromide
Droga: CHF 5993 100/6/12.5
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg; GB=Glycopyrronium Bromide 12.5µg.
Comparador activo: CHF 1535 100/6 µg

CHF 1535 100/6 µg CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF

BDP=Beclometasone Dipropionate bid=Twice daily FF=Formoterol Fumarate
Droga: CHF 1535 100/6 µg
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in pre-dose FEV1 was analysed at Week 26 of treatment.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 26.
2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Asthma exacerbation (events): Moderate AND Severe.

Severe: asthma worsening requiring initiation of treatment with systemic corticosteroids for at least 3 days (courses of corticosteroids separated by ≥1 week treated as separate severe exacerbations).

Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:

  • Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights/increase of ≥0.75 from baseline in daily symptom score on 2 consecutive days; increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase 4 puffs/day);
  • ≥20% decrease in peak expiratory flow from baseline on at least 2 consecutive mornings/evenings or ≥20% decrease in FEV1 from baseline;
  • Visit to the ER/trial site for asthma treatment not requiring systemic corticosteroid.
Week 0 (pre-treatment, baseline) to Week 52.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.
Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
Week 0 (pre-treatment, baseline) to Week 52.
3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
Periodo de tiempo: Week 0 (pre-treatment, baseline) and Week 26.

Peak FEV1 was analysed within 3 hours post-dose.

FEV1=Peak of forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) and Week 26.
4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in the average morning PEF over the 26-Week treatment.

PEF=Peak expiratory flow; is the volume of air forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26.
5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
Periodo de tiempo: The entire treatment period; up to Week 52.

Severe Asthma Exacerbation Rate over the 52-Week Treatment Period in a pre-specified pooled analysis of 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
The entire treatment period; up to Week 52.
6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Change from baseline in peak FEV1 (within 3 h post-dosing) at all clinical visits.

Baseline for pre-dose FEV1 was calculated as average of the FEV1 measurements (L) from the visit 2 (V2) Pre45min & V2 Pre15min. If one of the two pre-dose values was missing, the baseline was equal to the available pre-dose value.
Week 0 (pre-treatment, baseline) to Week 52.
7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.
Results show the change from baseline in pre-dose FEV1 at all clinical visits.
Week 0 (pre-treatment, baseline) to Week 52.
8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
Results show the percentage of patients classified as FEV1 responders at both Week 26 and Week 52. FEV1 response: Change from baseline in pre-dose morning FEV1 ≥ 100 mL.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Baseline definition: mean of two pre-dose FEV1 measurements at visit 2 (V2).

Results show the change from baseline in FEV1 area under the curve [AUC] (0-3h) at all subsequent visits (i.e. change from baseline of the AUC of the serial post-dose spirometry assessments till 3h post-dose).
Week 0 (pre-treatment, baseline) to Week 52.
10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

ACQ-7 Questionnaire.

Asthma Control Questionnaire-7 (ACQ-7) allows assessment of asthma control in individual patients.

The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on lung function (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control (no impairment) and 6 indicating poor control (maximum impairment). The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer.

Baseline for ACQ-7 was the total score recorded at Visit 2 (Week 0) of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. A negative change from baseline indicates improvement in lung function.
Week 0 (pre-treatment, baseline) to Week 52.
11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 26 and Week 52

Asthma Control Questionnaire (ACQ) and Asthma Control Questionnaire-7 (QAC-7) are defined in the description of Outcome measure 10 above.

An ACQ-7 response was defined as change from baseline (Week 0, pre-dose) in ACQ-7 score ≤ -0.5; non-response was defined as change from baseline in ACQ-7 score >-0.5 or missing data.

Results represent the responders (i.e. change from baseline in ACQ-7 Score ≤ -0.5) at Week 26 and Week 52.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52
12a_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Change from baseline in average MORNING PEF (L/min) over 52 weeks of treatment.

PEF=Peak expiratory flow; is the volume of air forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 52.
12b_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in average EVENING PEF (L/min) over 26 and 52 weeks of treatment.

PEF=Peak expiratory flow; is the volume of air forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Data were analysed for the number of patients at risk of a moderate or severe asthma exacerbation.

Results show the number of patients who had moderate or severe asthma exacerbation over the 52 weeks treatment period.
Week 0 (pre-treatment, baseline) to Week 52.
14_Number of Patients at Risk of Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Periodo de tiempo: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Data were analysed for the number of patients at risk of a severe asthma exacerbation in the pooled analysis of the two pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

Results show the number of patients who had a severe asthma exacerbation over the 52 weeks treatment period.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
15_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02.
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Moderate asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-055993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (pre-treatment, baseline) to Week 52.
16_Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (pre-treatment, baseline) to Week 52.
17_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Moderate and severe asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

Results show the number of participants with moderate and severe asthma exacerbation.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (pre-treatment, baseline) to Week 52.
18_Number of Patients at Risk of Moderate OR Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Time to first moderate or severe asthma exacerbation in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

Results show the number of participants with moderate or severe asthma exacerbation.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (pre-treatment, baseline) to Week 52.
19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.
Moderate asthma exacerbation rate over the 52-Week treatment period.
Week 0 (pre-treatment, baseline) to Week 52.
21a_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the average use of rescue medication over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
21b_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average use (puffs/day) of rescue medication in each inter-visit period.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
22a_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Change from baseline in the percentage of rescue medication-free days in each inter-visit period over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
22b_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of rescue medication-free days in each inter-visit period over the entire treatment.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
23a_Change From Baseline in the Average Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Data was collected through an electronic daily diary from screening to the end of the study.

Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Weeks of treatment.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

  • Morning (night-time asthma symptom score):

    • 0 No symptoms;
    • 1 Mild = Symptoms not causing awakening;
    • 2 Moderate = Discomfort enough to cause awakenings;
    • 3 Severe = Causing awakenings for most of the night/did not sleep at all.

  • Evening (daytime asthma symptom score):

    • 0 No symptoms;
    • 1 Mild = Aware of symptoms, which could be easily tolerated;
    • 2 Moderate = Discomfort enough to cause interference with daily activity;
    • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 52.
23b_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average daily asthma symptom scores in each inter-visit period over the entire treatment. Data was collected daily through an electronic diary from screening to the end of the study.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

  • Morning (night-time asthma symptom score):
  • 0 No symptoms;
  • 1 Mild = Symptoms not causing awakening;
  • 2 Moderate = Discomfort enough to cause awakenings;
  • 3 Severe = Causing awakenings for most of the night/did not sleep at all.
  • Evening (daytime asthma symptom score):
  • 0 No symptoms;
  • 1 Mild = Aware of symptoms, which could be easily tolerated;
  • 2 Moderate = Discomfort enough to cause interference with daily activity;
  • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 52.
24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Change from baseline in the percentage of asthma symptom-free days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Week treatment periods. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 52.
24b_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of asthma symptom-free days in each inter-visit periods over the entire treatment.

Data was collected through an electronic daily diary from screening to end of the study.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 52.
25a_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of asthma control days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity).
Week 0 (pre-treatment, baseline) to Week 52.
25b_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
Periodo de tiempo: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of asthma control days in each inter-visit period.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Data was collected through an electronic daily diary from screening to the end of the study

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity).
Week 0 (pre-treatment, baseline) to Week 52.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Eventos adversos y reacciones adversas a medicamentos
Periodo de tiempo: Hasta la Semana 52
Hasta la Semana 52
Colección de resultados de Economía de la Salud
Periodo de tiempo: Semana 0 a Semana 52
Consumo total de recursos sanitarios y absentismo laboral
Semana 0 a Semana 52

Colaboradores e Investigadores

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

Patrocinador

Chiesi Farmaceutici S.p.A.

Investigadores

  • Investigador principal: Christian Virchow, MD, Facharzt für Innere Medizin Rostock, Germany

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)

17 de febrero de 2016

Finalización primaria (Actual)

17 de mayo de 2018

Finalización del estudio (Actual)

17 de mayo de 2018

Fechas de registro del estudio

Enviado por primera vez

3 de febrero de 2016

Primero enviado que cumplió con los criterios de control de calidad

3 de febrero de 2016

Publicado por primera vez (Estimado)

8 de febrero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de junio de 2026

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

2 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-05993AB1-03
  • 2015-000716-18 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Chiesi se compromete a compartir con investigadores científicos y médicos calificados, realizar investigaciones legítimas, datos a nivel de paciente, datos a nivel de estudio, el protocolo clínico y el CSR completo, brindando acceso a la información de ensayos clínicos de manera consistente con el principio de salvaguardar la información comercial confidencial y el paciente. privacidad. Todos los datos compartidos a nivel de paciente se anonimizan para proteger la información de identificación personal.

Los criterios de acceso de Chiesi y el proceso completo para compartir datos clínicos están disponibles en el sitio web del Grupo Chiesi.

Criterios de acceso compartido de IPD

Los criterios de acceso de Chiesi y el proceso completo para compartir datos clínicos están disponibles en el sitio web del Grupo Chiesi.

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