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Um estudo em pacientes com doença pulmonar obstrutiva crônica (FUTURE)

24 de junho de 2026 atualizado por: Chiesi Farmaceutici S.p.A.

Um estudo de grupo paralelo de 12 semanas, multicêntrico, multinacional, randomizado, duplo-cego, duplo simulado, comparando a eficácia e a segurança de Foster® 100/6 (dipropionato de beclometasona 100 µg mais formoterol 6 µg/atuação), 2 Puffs b.i.d., Versus Seretide® 500/50 (Fluticasona 500 µg Mais Salmeterol 50 µg/Atuação), 1 Inalação b.i.d., em Pacientes com Doença Pulmonar Obstrutiva Crônica

O objetivo do presente estudo é determinar os efeitos sobre o estado de saúde e os valores espirométricos de Foster® 100/6 (duas inalações b.i.d.) versus Seretide® 500/50 (uma inalação b.i.d.), durante um período de tratamento de 12 semanas em Obstrução Crônica Pacientes com Doença Pulmonar (DPOC).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

A doença pulmonar obstrutiva crônica (DPOC) é uma doença incurável, debilitante e progressiva que pode ser fatal. O recente Global Burden of Disease Study classifica a DPOC como a 6ª principal causa de mortalidade e a 12ª principal causa de morbidade em todo o mundo. Além disso, as tendências no uso de recursos de cuidados médicos indicam que o custo econômico da DPOC continua a aumentar em relação direta com o envelhecimento da população, o aumento da prevalência da doença e o custo de novas e existentes intervenções médicas e de saúde pública.

Tipo de estudo

Intervencional

Inscrição (Real)

419

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  1. Pacientes do sexo masculino ou feminino com idade ≥ 40 anos, que assinaram um Termo de Consentimento Livre e Esclarecido antes do início de qualquer procedimento relacionado ao estudo ou, uma vez aplicável, consentimento informado por escrito obtido pelo representante legal.

  2. Pacientes ambulatoriais com diagnóstico de DPOC e incluindo:

    1. História de tabagismo de pelo menos 10 anos maços definido como [(número de cigarros fumados por dia) x (número de anos de tabagismo) / 20], tanto fumantes atuais quanto ex-fumantes são elegíveis.
    2. Uso de broncodilatadores nos 2 meses anteriores à consulta 1.
    3. VEF1 pós-broncodilatador < 60% do valor normal previsto.
    4. VEF1/CVF pós-broncodilatador < 0,7.
    5. Uma resposta ≥ 5% a um teste de reversibilidade.
    6. Uma pontuação focal do Índice de dispneia basal (BDI) menor ou igual a 10 (a ser atendida também na visita 2).
  3. História de não mais de uma exacerbação de DPOC nos últimos 12 meses (sem considerar os últimos 2 meses) para visitar 1.
  4. Uma atitude cooperativa e capacidade de ser treinado para o uso adequado dos inaladores pMDI e DPI (Accuhaler®, inalador circular de plástico moldado).

Principais Critérios de Exclusão:

  1. Distúrbios respiratórios clinicamente relevantes.
  2. Diagnóstico atual de asma ou distúrbios respiratórios diferentes da DPOC.
  3. Anormalidades laboratoriais e de ECG clinicamente significativas indicando uma doença concomitante significativa ou instável que pode afetar a viabilidade dos resultados do estudo de acordo com o julgamento do investigador.
  4. Pacientes com exacerbação da DPOC nos 2 meses anteriores à triagem e durante o período do estudo.
  5. Pacientes que necessitam de oxigenoterapia de longo prazo (pelo menos 12 horas diárias) para hipoxemia crônica.
  6. Pacientes tratados com corticosteroides de depósito nos 2 meses anteriores à visita 1 e durante o período inicial.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: Beclomethasone Dipropionate - Formoterol
Administered via a pressurized metered-dose inhaler
Outros nomes:
  • Fomentar
Comparador Ativo: 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.
Medicamento: Fluticasone - Salmeterol
Administered via a pressurized metered-dose inhaler
Outros nomes:
  • Seretide Accuhaler®

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

12 de abril de 2011

Conclusão Primária (Real)

13 de março de 2012

Conclusão do estudo (Real)

13 de março de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

19 de novembro de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de novembro de 2010

Primeira postagem (Estimado)

22 de novembro de 2010

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

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Outros números de identificação do estudo

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

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