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Uno studio su pazienti con broncopneumopatia cronica ostruttiva (FUTURE)

24 giugno 2026 aggiornato da: Chiesi Farmaceutici S.p.A.

Uno studio di 12 settimane, multicentrico, multinazionale, randomizzato, in doppio cieco, double-dummy, a gruppi paralleli a 2 bracci che confronta l'efficacia e la sicurezza di Foster® 100/6 (beclometasone dipropionato 100 µg più formoterolo 6 µg/erogazione), 2 Puffs b.i.d., Versus Seretide® 500/50 (Fluticasone 500 µg Plus Salmeterol 50 µg/Actuation), 1 inalazione b.i.d., in pazienti con broncopneumopatia cronica ostruttiva

Lo scopo del presente studio è quello di determinare gli effetti sullo stato di salute e sui valori spirometrici di Foster® 100/6 (due puff b.i.d.) rispetto a Seretide® 500/50 (una inalazione b.i.d.), per un periodo di trattamento di 12 settimane in pazienti affetti da malattia cronica ostruttiva. Pazienti con malattie polmonari (BPCO).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

La broncopneumopatia cronica ostruttiva (BPCO) è una malattia incurabile, debilitante e progressiva che può essere fatale. Il recente Global Burden of Disease Study classifica la BPCO come la sesta causa di mortalità e la dodicesima causa di morbilità a livello mondiale. Inoltre, le tendenze nell'uso delle risorse sanitarie indicano che il costo economico della BPCO continua a crescere in relazione diretta all'invecchiamento della popolazione, all'aumento della prevalenza della malattia e al costo degli interventi medici e di sanità pubblica nuovi ed esistenti.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

419

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Danimarca
      • Aarhus, Danimarca
        • Aarhus University Hospital
      • Copenhagen, Danimarca
        • Bispebjerg Hospital
      • Copenhagen, Danimarca
        • Dept. of Cardiology and Respiratory Medicine
      • Gentofte Municipality, Danimarca
        • Gentofte Hospital
      • Odense, Danimarca
        • Odense University Hospital
  • Francia
      • Toulon, Francia
        • Centre Hospitalier
  • Germania
      • Berlin, Germania
        • Praxis Dr. Jorg Kampschulte
      • Leipzig, Germania
        • Praxis Dr. Jörg Winkler
      • Lübeck, Germania
        • KLB Healthresearch
      • Lübeck, Germania
        • KLD Helthreseach
      • Magdeburg, Germania
        • SMO.MD GmbH Zentrum für Klinische Studien
      • Saarbrücken, Germania
        • Pneumologische Gemeinschaftspraxis Saarbrücken
      • Wedel, Germania
        • Fachinternistische Gemeinschafts
      • Wiesloch, Germania
        • Pneumologische Praxis Dr Redlich
      • Wuppertal, Germania
        • Gemeinschaftspraxis für Pneumologie
  • 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)
  • Regno Unito
      • Belfast, Regno Unito
        • Belfast City Hospital
      • London, Regno Unito
        • Kings College Hospital
      • Newcastle, Regno Unito
        • Freeman Hospital
  • Slovacchia
      • Humenné, Slovacchia
        • Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
      • Nové Zámky, Slovacchia
        • Diunea, sro. Ambulancia PaF
      • Ostrov, Slovacchia
        • ALERGOIMUNO s.r.o
      • Poprad, Slovacchia
        • Pľúcna ambulancia, Poliklinika ADUS
      • Prešov, Slovacchia
        • PULMO, s.r.o
      • Prievidza, Slovacchia
        • PNEUMO-MED, s.r.o
      • Spišská Nová Ves, Slovacchia
        • Pľúcna ambulancia, Hrebenár s.r.o
      • Trnava, Slovacchia
        • PNEUMO-CENTRUM, s.r.o, Poliklinika
  • Spagna
      • Barcelona, Spagna
        • Hospital Del Mar
      • Sabadell, Spagna
        • Hospital Parc Tauli
      • Vic, Spagna
        • Hospital General Vic
  • Turchia (Türkiye)
      • Adana, Turchia (Türkiye)
        • Çukurova Üniversitesi
      • Antalya, Turchia (Türkiye)
        • Akdeniz Universitesi
      • Antalya, Turchia (Türkiye)
        • Bilim Üniversitesi
      • Bornova, Turchia (Türkiye)
        • Ege Üniversitesi
      • Bursa, Turchia (Türkiye)
        • Uludağ Üniversitesi
      • Gaziantep, Turchia (Türkiye)
        • Gaziantep Üniversitesi
      • Istanbul, Turchia (Türkiye)
        • Fatih Üniversitesi
      • Istanbul, Turchia (Türkiye)
        • Marmara Üniversitesi
      • Izmir, Turchia (Türkiye)
        • Dokuz Eylul Universitesi
      • Kayseri, Turchia (Türkiye)
        • Erciyes Üniversitesi
  • Ungheria
      • Balassagyarmat, Ungheria
        • Dr. Kenessey Albert Kórház - Rendelőintézet
      • Budapest, Ungheria
        • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
      • Békés, Ungheria
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Debrecen, Ungheria
        • Centrum-Tüdőgyógyászati Klinika
      • Kecskemét, Ungheria
        • Bács-Kiskun Megeyi Önkormanyzat...
      • Mosonmagyaróvár, Ungheria
        • Karolina Kórház és Rendelőintézet Tüdőgyógyászat
      • Nyíregyháza, Ungheria
        • Jósa András Hospital
      • Nyíregyháza, Ungheria
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Szigetszentmiklös, Ungheria
        • Chiesi Clinical Centre Szigetszentmiklös

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  1. Pazienti di sesso maschile o femminile di età ≥ 40 anni, che hanno firmato un modulo di consenso informato prima dell'inizio di qualsiasi procedura correlata allo studio o, una volta applicabile, il consenso informato scritto ottenuto dal rappresentante legale.

  2. Pazienti ambulatoriali con diagnosi di BPCO e inclusi:

    1. Storia del fumo di almeno 10 pacchetti anno definita come [(numero di sigarette fumate al giorno) x (numero di anni di fumo) / 20], sono ammissibili sia i fumatori attuali che gli ex fumatori.
    2. Uso di broncodilatatori nei 2 mesi precedenti alla visita 1.
    3. FEV1 post-broncodilatatore < 60% del valore normale previsto.
    4. FEV1/FVC post-broncodilatatore < 0,7.
    5. Una risposta ≥ 5% a un test di reversibilità.
    6. Un punteggio focale dell'indice di dispnea al basale (BDI) inferiore o uguale a 10 (da raggiungere anche alla visita 2).
  3. Anamnesi di non più di una riacutizzazione di BPCO nei 12 mesi precedenti (senza considerare gli ultimi 2 mesi) da visitare 1.
  4. Un atteggiamento collaborativo e la capacità di essere addestrati all'uso corretto di inalatori pMDI e DPI (Accuhaler®, inalatore di plastica stampato circolare).

Principali criteri di esclusione:

  1. Patologie respiratorie clinicamente rilevanti.
  2. Diagnosi attuale di asma o disturbi respiratori diversi dalla BPCO.
  3. Anomalie di laboratorio ed ECG clinicamente significative che indicano una malattia concomitante significativa o instabile che può influire sulla fattibilità dei risultati dello studio secondo il giudizio dello sperimentatore.
  4. Pazienti con riacutizzazione della BPCO nei 2 mesi precedenti lo screening e durante il periodo di studio.
  5. Pazienti che richiedono ossigenoterapia a lungo termine (almeno 12 ore al giorno) per ipossiemia cronica.
  6. Pazienti trattati con corticosteroidi depot nei 2 mesi precedenti la visita 1 e durante il periodo di rodaggio.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altri nomi:
  • Allevare
Comparatore attivo: 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
Altri nomi:
  • Seretide Accuhaler®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 aprile 2011

Completamento primario (Effettivo)

13 marzo 2012

Completamento dello studio (Effettivo)

13 marzo 2012

Date di iscrizione allo studio

Primo inviato

19 novembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

19 novembre 2010

Primo Inserito (Stimato)

22 novembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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