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Un estudio en pacientes con enfermedad pulmonar obstructiva crónica (FUTURE)

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

Estudio de 12 semanas, multicéntrico, multinacional, aleatorizado, doble ciego, con doble simulación, de grupos paralelos de 2 brazos que compara la eficacia y la seguridad de Foster® 100/6 (dipropionato de beclometasona 100 µg más formoterol 6 µg/actuación), 2 Puffs b.i.d., Versus Seretide® 500/50 (Fluticasone 500 µg Plus Salmeterol 50 µg/Actuation), 1 inhalación b.i.d., en pacientes con enfermedad pulmonar obstructiva crónica

El propósito del presente estudio es determinar los efectos sobre el estado de salud y los valores espirométricos de Foster® 100/6 (dos inhalaciones dos veces al día) versus Seretide® 500/50 (una inhalación dos veces al día), durante un período de tratamiento de 12 semanas en pacientes con enfermedad obstructiva crónica. Pacientes con enfermedad pulmonar (EPOC).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

La enfermedad pulmonar obstructiva crónica (EPOC) es una enfermedad incurable, debilitante y progresiva que puede ser mortal. El reciente estudio Global Burden of Disease clasifica a la EPOC como la sexta causa principal de mortalidad y la duodécima causa principal de morbilidad en todo el mundo. Además, las tendencias en el uso de los recursos de atención médica indican que el costo económico de la EPOC sigue aumentando en relación directa con el envejecimiento de la población, el aumento de la prevalencia de la enfermedad y el costo de las intervenciones médicas y de salud pública nuevas y existentes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

419

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
      • Berlin, Alemania
        • Praxis Dr. Jorg Kampschulte
      • Leipzig, Alemania
        • Praxis Dr. Jörg Winkler
      • Lübeck, Alemania
        • KLB Healthresearch
      • Lübeck, Alemania
        • KLD Helthreseach
      • Magdeburg, Alemania
        • SMO.MD GmbH Zentrum für Klinische Studien
      • Saarbrücken, Alemania
        • Pneumologische Gemeinschaftspraxis Saarbrücken
      • Wedel, Alemania
        • Fachinternistische Gemeinschafts
      • Wiesloch, Alemania
        • Pneumologische Praxis Dr Redlich
      • Wuppertal, Alemania
        • Gemeinschaftspraxis für Pneumologie
  • Dinamarca
      • Aarhus, Dinamarca
        • Aarhus University Hospital
      • Copenhagen, Dinamarca
        • Bispebjerg Hospital
      • Copenhagen, Dinamarca
        • Dept. of Cardiology and Respiratory Medicine
      • Gentofte Municipality, Dinamarca
        • Gentofte Hospital
      • Odense, Dinamarca
        • Odense University Hospital
  • Eslovaquia
      • Humenné, Eslovaquia
        • Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
      • Nové Zámky, Eslovaquia
        • Diunea, sro. Ambulancia PaF
      • Ostrov, Eslovaquia
        • ALERGOIMUNO s.r.o
      • Poprad, Eslovaquia
        • Pľúcna ambulancia, Poliklinika ADUS
      • Prešov, Eslovaquia
        • PULMO, s.r.o
      • Prievidza, Eslovaquia
        • PNEUMO-MED, s.r.o
      • Spišská Nová Ves, Eslovaquia
        • Pľúcna ambulancia, Hrebenár s.r.o
      • Trnava, Eslovaquia
        • PNEUMO-CENTRUM, s.r.o, Poliklinika
  • España
      • Barcelona, España
        • Hospital Del Mar
      • Sabadell, España
        • Hospital Parc Tauli
      • Vic, España
        • Hospital General Vic
  • Francia
      • Toulon, Francia
        • Centre Hospitalier
  • Hungría
      • Balassagyarmat, Hungría
        • Dr. Kenessey Albert Kórház - Rendelőintézet
      • Budapest, Hungría
        • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
      • Békés, Hungría
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Debrecen, Hungría
        • Centrum-Tüdőgyógyászati Klinika
      • Kecskemét, Hungría
        • Bács-Kiskun Megeyi Önkormanyzat...
      • Mosonmagyaróvár, Hungría
        • Karolina Kórház és Rendelőintézet Tüdőgyógyászat
      • Nyíregyháza, Hungría
        • Jósa András Hospital
      • Nyíregyháza, Hungría
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Szigetszentmiklös, Hungría
        • Chiesi Clinical Centre Szigetszentmiklös
  • Italia
      • Bologna, Italia
        • Ospedale Sant'Orsola-Malpighi
      • Catania, Italia
        • A.O. Policlinico
      • Monza, Italia
        • A.O. S. Gerardo
      • Naples, Italia
        • Azienda Ospedaliera Monaldi
      • Pisa, Italia
        • Universita di Pisa
      • Roma, Italia
        • IRCCS San Raffaele La Pisana
      • Rome, Italia, 00161
        • Policlinico Umberto I - VIII Padiglione
  • Polonia
      • Gdansk, Polonia
        • NZOZ "Non Nocere"
      • Koszalin, Polonia
        • Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"
      • Krakow, Polonia
        • Szpital Uniwersytecki w Krakowie
      • Krakow, Polonia
        • Szpital Specjalistyczny im Jana Pawła II
      • Lodz, Polonia
        • Prywatny Gabinet Specjalistyczny
      • Szczecin, Polonia
        • Samodzielny Publiczny Szpital Kliniczny
      • Warsaw, Polonia
        • Chorób Płuc
      • Warsaw, Polonia
        • Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA
      • Warsaw, Polonia
        • Instytut Gruźlicy i Chorób Płuc. Zakład Diagnostyki i Leczenia Niewydolności Oddychania
      • Warsaw, Polonia
        • Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc
      • Wroclaw, Polonia
        • DOBROSTAN - Gabinety Lekarskie
      • Wroclaw, Polonia
        • NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy
      • Zgierz, Polonia
        • Wojewódzki Szpital Specjalistyczny im. M. Curie-Skłodowskiej)
  • Reino Unido
      • Belfast, Reino Unido
        • Belfast City Hospital
      • London, Reino Unido
        • Kings College Hospital
      • Newcastle, Reino Unido
        • Freeman Hospital
  • Turquía (Türkiye)
      • Adana, Turquía (Türkiye)
        • Çukurova Üniversitesi
      • Antalya, Turquía (Türkiye)
        • Akdeniz Universitesi
      • Antalya, Turquía (Türkiye)
        • Bilim Üniversitesi
      • Bornova, Turquía (Türkiye)
        • Ege Üniversitesi
      • Bursa, Turquía (Türkiye)
        • Uludağ Üniversitesi
      • Gaziantep, Turquía (Türkiye)
        • Gaziantep Üniversitesi
      • Istanbul, Turquía (Türkiye)
        • Fatih Üniversitesi
      • Istanbul, Turquía (Türkiye)
        • Marmara Üniversitesi
      • Izmir, Turquía (Türkiye)
        • Dokuz Eylul Universitesi
      • Kayseri, Turquía (Türkiye)
        • Erciyes Üniversitesi

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

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  1. Pacientes masculinos o femeninos de ≥ 40 años, que hayan firmado un formulario de consentimiento informado antes del inicio de cualquier procedimiento relacionado con el estudio o, una vez que corresponda, el consentimiento informado por escrito obtenido por el representante legal.

  2. Pacientes ambulatorios con diagnóstico de EPOC e incluyendo:

    1. Historial de tabaquismo de al menos 10 paquetes por año definido como [(número de cigarrillos fumados por día) x (número de años de tabaquismo) / 20], tanto los fumadores actuales como los exfumadores son elegibles.
    2. Uso de broncodilatadores en los 2 meses previos a la visita 1.
    3. FEV1 posbroncodilatador < 60% del valor normal previsto.
    4. FEV1/FVC posbroncodilatador < 0,7.
    5. Una respuesta ≥ 5% a una prueba de reversibilidad.
    6. Una puntuación focal del índice de disnea basal (BDI) inferior o igual a 10 (que se cumplirá también en la visita 2).
  3. Historia de no más de una exacerbación de la EPOC en los 12 meses previos (sin considerar los 2 últimos meses) a la visita 1.
  4. Una actitud cooperativa y la capacidad de recibir capacitación sobre el uso adecuado de los inhaladores pMDI y DPI (Accuhaler®, inhalador de plástico moldeado circular).

Principales Criterios de Exclusión:

  1. Trastornos respiratorios clínicamente relevantes.
  2. Diagnóstico actual de asma o trastornos respiratorios distintos de la EPOC.
  3. Anormalidades de laboratorio y ECG clínicamente significativas que indiquen una enfermedad concomitante significativa o inestable que puede afectar la viabilidad de los resultados del estudio según el juicio del investigador.
  4. Pacientes con exacerbación de la EPOC en los 2 meses previos a la selección y durante el período de estudio.
  5. Pacientes que requieren terapia de oxígeno a largo plazo (al menos 12 horas diarias) para la hipoxemia crónica.
  6. Pacientes tratados con corticoides de depósito en los 2 meses anteriores a la visita 1 y durante el período de preinclusión.

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®
Participants received 2 puffs of Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI twice daily (BID), resulting in a total daily dose of beclomethasone dipropionate 400 μg plus formoterol 24 μg, for a duration of 12 weeks. To ensure blinding, participants received one inhalation of placebo matching Seretide® Accuhaler® via a inhaler BID, for a duration of 12 weeks.
Droga: Beclomethasone Dipropionate - Formoterol
Administered via a pressurized metered-dose inhaler
Otros nombres:
  • Fomentar
Comparador activo: Seretide® Accuhaler®
Participants received one inhalation of Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation) administered via inhaler, BID resulting in a total daily dose of fluticasone 1000 μg plus salmeterol 100 μg, for a duration of 12 weeks. To ensure blinding, participants receieved two puffs of placebo matching Foster® via pMDI, BID for a duration of 12 weeks.
Droga: Fluticasone - Salmeterol
Administered via a pressurized metered-dose inhaler
Otros nombres:
  • Seretide Accuhaler®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1
Periodo de tiempo: on Day 1 (V2)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessment were implemented at pre-dose, and 5, 15 and 30 minutes post inhalation
on Day 1 (V2)
Transition Dyspnoea Index (TDI) Score at Day 84
Periodo de tiempo: Day 84 (V5)

TDI has three domains as follows:

  1. Functional impairment, which determines the impact of breathlessness on the ability to carry out activities;
  2. Magnitude of task, which determines the type of task that causes breathlessness;
  3. Magnitude of effort, which establishes the level of effort that results in breathlessness

The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score of -9 (major deterioration) to +9 (major improvement).

Adjusted means were reported.
Day 84 (V5)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
Periodo de tiempo: on Day 84 (V5)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented pre-dose, 5, 15 and 30 minutes post inhalation.
on Day 84 (V5)
AUC 0-30min Standardized by Time of Change From Baseline in FEV1 After Drug Inhalation in the Morning of Day 84
Periodo de tiempo: on Day 84 (V5)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented at baseline and 5,15 and 30 minutes post inhalation.
on Day 84 (V5)
Change From Baseline (CFB) in Pre-dose Morning FEV1
Periodo de tiempo: Weeks 4, 8 and 12
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.
Weeks 4, 8 and 12
Change From Baseline in Pre-dose Morning Forced Vital Capacity (FVC)
Periodo de tiempo: Weeks 4, 8 and 12
FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.
Weeks 4, 8 and 12
Change From Pre-dose in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
Periodo de tiempo: 5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.
5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)
Change From Baseline in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
Periodo de tiempo: at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.
at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)
Change From Pre-dose in Morning FVC at 5, 15 and 30 Min After Drug Intake
Periodo de tiempo: at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)
FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.
at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)
Change From Baseline to Each Two-Week Period in COPD Symptom Scores
Periodo de tiempo: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

COPD symptom scores consists of following 6 items recorded by the participants in diary.

  • the ability to perform the usual daily activities;
  • breathlessness over the previous 24h;
  • waking at night due to respiratory symptoms;
  • breathlessness on rising;
  • cough over the previous 24h;
  • sputum production over the previous 24h.

Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). Baseline COPD symptom score has been calculated as the mean of the COPD symptom scores recorded in the run-in period. Each item or total scores were averaged over each 2 week period. Average COPD symptom score in each two-week period has been calculated as the mean of the item or total score recorded in each two-week period. Adjusted means were reported.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Each Two-Week Period in Percentage of COPD Symptom-Free Days
Periodo de tiempo: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

COPD symptom scores consists of following 6 items recorded by the participants in diary.

  • ability to perform the usual daily activities;
  • breathlessness over the previous 24h;
  • waking at night due to respiratory symptoms;
  • breathlessness on rising;
  • cough over the previous 24h;
  • sputum production over the previous 24h.

Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst).

A COPD symptom-free day is a day with total COPD symptom scores = 0. Baseline % of COPD symptom-free days is calculated as the % ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100.

Reported values (in form of adjusted means) reflect a percentage (%).

% of COPD symptom-free days in each two-week period is calculated as % (ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Entire Treatment Period in Percentage of COPD Symptom-Free Days
Periodo de tiempo: Baseline, Weeks 1 through 12

COPD symptom scores consists of following 6 items recorded by the participants in diary.

  • ability to perform the usual daily activities;
  • breathlessness over the previous 24h;
  • waking at night due to respiratory symptoms;
  • breathlessness on rising;
  • cough over the previous 24h;
  • sputum production over the previous 24h.

Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst).

A COPD symptom-free day is a day with total COPD symptom scores = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of COPD symptom-free days is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100.

% of COPD symptom-free days in each two-week period is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100.
Baseline, Weeks 1 through 12
Change From Baseline to Each Two-Week Period in Average Use of Rescue Salbutamol Consumption
Periodo de tiempo: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Number of rescue salbutamol puffs per day were recorded in the diary. Baseline use of rescue medication has been calculated as the mean number of puffs per day in the run-in period. Average use of rescue medication in each two-week period has been calculated as the mean number of puffs per day in each two week period. Adjusted means were reported.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Each Two-Week Period in Percentage of Rescue Salbutamol-Free Days
Periodo de tiempo: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

A rescue medication-free day is a day with number of puffs of rescue medication = 0.

Reported values (in form of adjusted means) reflect a percentage (%). Baseline percentage (%) of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100.

% of rescue medication-free days in each two-week period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the two-week period)*100.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Entire Treatment Period in Percentage of Rescue Salbutamol-Free Days
Periodo de tiempo: at week 12 (V5)

A rescue medication-free day is a day with number of puffs of rescue medication = 0.

Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100.

% of rescue medication-free days in the entire treatment period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the entire treatment period)*100.
at week 12 (V5)
Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Component and Total Scores
Periodo de tiempo: at Week 12 (V5)

SGRQ is a 76-item questionnaire developed to measure health in chronic airflow limitation and designed to be self-completed by the participant. It consists of 76-items across three domains:

  • Symptoms, which evaluates the frequency and severity of respiratory issues like coughing, sputum production, and breathlessness;
  • Activity, which measures limitations in physical activities due to breathlessness;
  • Impacts, which examines psychological and social effects, including feelings of stigma, loss of control, and daily life disruption.

Each domain score ranges from 0 to 100 with higher scores indicating the worst health status. Total score was obtained by combining the weighted scores from each domain and ranging from 0 (better health) to 100 (Worst health).
at Week 12 (V5)
Change From Baseline in Pre-dose and in Post-dose Distance Walked (6 Minute Walking Test - 6MWT)
Periodo de tiempo: Week 12 (V5), pre-dose and post-dose
The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start. The longer distance covered, the better the outcome.
Week 12 (V5), pre-dose and post-dose
Change From Pre-dose in Post-dose Distance Walked (6MWT)
Periodo de tiempo: on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)
The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start.
on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)
Number of Participants With COPD Exacerbations From Week 0 Through Week 12
Periodo de tiempo: Week 12
A COPD exacerbation is defined as "a sustained worsening of the participants condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and requires unscheduled medical intervention [leading to prescriptions of systemic corticosteroids (at least 3 days)] and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization) in a participant with underlying COPD".
Week 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Periodo de tiempo: From first dose of study drug until end of the treatment (up to 84 days)

AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine.

Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.

ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.

Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense.
From first dose of study drug until end of the treatment (up to 84 days)

Colaboradores e Investigadores

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

Patrocinador

Chiesi Farmaceutici S.p.A.

Investigadores

  • Investigador principal: Dave Singh, MD, The Medicine Evaluation Unit - Manchester, UK
  • Investigador principal: Jorgen Vestbo, MD, Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark

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)

12 de abril de 2011

Finalización primaria (Actual)

13 de marzo de 2012

Finalización del estudio (Actual)

13 de marzo de 2012

Fechas de registro del estudio

Enviado por primera vez

19 de noviembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

19 de noviembre de 2010

Publicado por primera vez (Estimado)

22 de noviembre de 2010

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

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Términos relacionados con este estudio

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Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CCD-0910-PR-0021
  • 2009-014410-10 (Número EudraCT)

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