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En studie på patienter med kronisk obstruktiv lungsjukdom (FUTURE)

24 juni 2026 uppdaterad av: Chiesi Farmaceutici S.p.A.

En 12-veckors, multicenter, multinationell, randomiserad, dubbelblind, dubbeldummy, 2-armad parallell gruppstudie som jämför effektiviteten och säkerheten för Foster® 100/6 (Beklometasondipropionat 100 µg Plus Formoterol 6 µg/aktivering), 2 Bloss b.i.d., Versus Seretide® 500/50 (Fluticason 500 µg Plus Salmeterol 50 µg/aktivering), 1 inhalation b.i.d., hos patienter med kronisk obstruktiv lungsjukdom

Syftet med denna studie är att fastställa effekterna på hälsostatus och spirometriska värden av Foster® 100/6 (två bloss b.i.d.) kontra Seretide® 500/50 (en inhalation b.i.d.), under en 12-veckors behandlingsperiod vid kronisk obstruktiv behandling. Patienter med lungsjukdom (KOL).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Kronisk obstruktiv lungsjukdom (KOL) är en obotlig, försvagande och progressiv sjukdom som kan vara dödlig. Den nyligen genomförda Global Burden of Disease-studien rankar KOL som den sjätte vanligaste dödsorsaken och den 12:e vanligaste orsaken till sjuklighet över hela världen. Dessutom indikerar trender i användningen av sjukvårdsresurser att de ekonomiska kostnaderna för KOL fortsätter att stiga i direkt relation till den åldrande befolkningen, ökningen av sjukdomsprevalensen och kostnaderna för nya och befintliga medicinska och folkhälsoinsatser.

Studietyp

Interventionell

Inskrivning (Faktisk)

419

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  1. Manliga eller kvinnliga patienter i åldern ≥ 40 år, som har undertecknat ett formulär för informerat samtycke innan ett studierelaterat förfarande påbörjas eller en gång tillämpligt skriftligt informerat samtycke erhållits av juridiskt ombud.

  2. Polikliniska patienter med diagnosen KOL och inklusive:

    1. Rökhistorik på minst 10 packår definierat som [(antal cigaretter rökta per dag) x (antal år av rökning) / 20], både nuvarande och före detta rökare är berättigade.
    2. Användning av luftrörsvidgare under de senaste 2 månaderna för att besöka 1.
    3. Post-bronkdilaterande FEV1 < 60 % av det förväntade normalvärdet.
    4. Post-bronkdilaterande FEV1/FVC < 0,7.
    5. En ≥ 5 % respons på ett reversibilitetstest.
    6. Ett baseline Dyspné Index (BDI) fokalpoäng som är mindre eller lika med 10 (ska uppfyllas även vid besök 2).
  3. Historik om inte mer än en KOL-exacerbation under de senaste 12 månaderna (utan att beakta de senaste 2 månaderna) för att besöka 1.
  4. En samarbetsvillig attityd och förmåga att tränas i korrekt användning av pMDI och DPI (Accuhaler®, cirkulär formgjuten plastinhalator) inhalatorer.

Huvudsakliga uteslutningskriterier:

  1. Kliniskt relevanta andningsstörningar.
  2. Aktuell diagnos av astma eller andra andningssjukdomar än KOL.
  3. Kliniskt signifikanta laboratorie- och EKG-avvikelser som indikerar en signifikant eller instabil samtidig sjukdom som kan påverka genomförbarheten av resultaten av studien enligt utredarens bedömning.
  4. Patienter med KOL-exacerbation under de 2 månaderna före screening och under studieperioden.
  5. Patienter som behöver långvarig (minst 12 timmar dagligen) syrgasbehandling för kronisk hypoxemi.
  6. Patienter som behandlats med depåkortikosteroider under de 2 månaderna före besök 1 och under inkörningsperioden.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Beclomethasone Dipropionate - Formoterol
Administered via a pressurized metered-dose inhaler
Andra namn:
  • Främja
Aktiv komparator: 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.
Läkemedel: Fluticasone - Salmeterol
Administered via a pressurized metered-dose inhaler
Andra namn:
  • Seretide Accuhaler®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chiesi Farmaceutici S.p.A.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 april 2011

Primärt slutförande (Faktisk)

13 mars 2012

Avslutad studie (Faktisk)

13 mars 2012

Studieregistreringsdatum

Först inskickad

19 november 2010

Först inskickad som uppfyllde QC-kriterierna

19 november 2010

Första postat (Beräknad)

22 november 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

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