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POTRÓJNE w astmie z niekontrolowanym pacjentem przy średniej sile ICS + LABA (TRIMARAN)

2 czerwca 2026 zaktualizowane przez: Chiesi Farmaceutici S.p.A.

52-TYGODNIOWE, RÓWNOLEGŁE BADANIE GRUPOWE Z PODWÓJNĄ ŚLEPĄ, MIĘDZYNARODOWE, WIELONARODOWE, KONTROLOWANE AKTYWNIE, 2-RAMIENNE, PORÓWNAJĄCE RÓWNOLEGŁE CHF 5993 100/6/12,5 µg pMDI (STAŁA KOMBINACJA BARDZO Drobnego Dipropionianu Beklometazonu PLUS FORMOTEROLU FUMARANU PLUS GLIKOPIROROMU BROMKU 1053) /6 µg pMDI (STAŁA KOMBINACJA BARDZO DOBRYCH DIPROPIONIANU BEKLOMETAZONU PLUS FUMARANU FORMOTEROLU) U PACJENTÓW Z NIEKONTROLOWANĄ ASTMĄ PODCZAS ŚREDNICH DAWEK WDYCHALNYCH KORTYKOSTEROIDÓW W POŁĄCZENIU Z DŁUGO DZIAŁAJĄCYMI ß2-AGONISTAMI

Celem tego badania jest ocena wyższości CHF 5993 100/6/12,5 µg pMDI (ustalona kombinacja bardzo drobnego dipropionianu beklometazonu plus fumaran formoterolu i bromek glikopironowy) w porównaniu z CHF 1535 100/6 µg pMDI (ustalona kombinacja bardzo drobnego dipropionianu beklometazonu i fumaranu formoterolu) pod względem parametrów czynności płuc i częstości zaostrzeń, a także ocenić jego bezpieczeństwo i niektóre wyniki ekonomiki zdrowia.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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

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

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

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

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

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

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1155

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Historia astmy ≥ 1 rok i zdiagnozowana przed 40 rokiem życia
  • Niekontrolowana astma z podwójną terapią tylko średnimi dawkami wziewnego kortykosteroidu (ICS) w połączeniu z długo działającym beta2-agonistą (LABA) z ACQ-7 (kwestionariusz kontroli astmy) ≥1,5
  • FEV1 przed podaniem leku rozszerzającego oskrzela <80% wartości należnej normy
  • Pozytywny test odwracalności
  • Co najmniej 1 udokumentowane zaostrzenie astmy w poprzednim roku

Kryteria wyłączenia:

  • Kobiety w ciąży lub karmiące piersią
  • Diagnostyka przewlekłej obturacyjnej choroby płuc (POChP)
  • Pacjenci z jakimkolwiek zaostrzeniem astmy lub infekcją dróg oddechowych w ciągu 4 tygodni przed badaniem przesiewowym
  • Obecni lub byli palacze (>= 10 paczek rocznie)
  • Jakakolwiek zmiana dawki, schematu lub preparatu kombinacji ICS + LABA w ciągu 4 tygodni poprzedzających badanie przesiewowe

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: CHF 5993 100/6/12.5 µg

CHF 5993 100/6/12.5

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

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

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

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26.

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

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

Asthma exacerbation (events): Moderate AND Severe.

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

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

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.
Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
Week 0 (pre-treatment, baseline) to Week 52.
3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
Ramy czasowe: Week 0 (pre-treatment, baseline) and Week 26.

Peak FEV1 was analysed within 3 hours post-dose.

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

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

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

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

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

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

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

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

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

ACQ-7 Questionnaire.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  • Morning (night-time asthma symptom score):

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

  • Evening (daytime asthma symptom score):

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Zdarzenia niepożądane i niepożądane reakcje na leki
Ramy czasowe: Do tygodnia 52
Do tygodnia 52
Zbiór wyników ekonomii zdrowia
Ramy czasowe: Tydzień 0 do Tydzień 52
Całkowite wykorzystanie zasobów opieki zdrowotnej i nieobecności w pracy
Tydzień 0 do Tydzień 52

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Chiesi Farmaceutici S.p.A.

Śledczy

  • Główny śledczy: Christian Virchow, MD, Facharzt für Innere Medizin Rostock, Germany

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

17 lutego 2016

Zakończenie podstawowe (Rzeczywisty)

17 maja 2018

Ukończenie studiów (Rzeczywisty)

17 maja 2018

Daty rejestracji na studia

Pierwszy przesłany

3 lutego 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 lutego 2016

Pierwszy wysłany (Szacowany)

8 lutego 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CCD-05993AB1-03
  • 2015-000716-18 (Numer EudraCT)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Chiesi zobowiązuje się do udostępniania wykwalifikowanym naukowcom i naukowcom medycznym, prowadzącym legalne badania, Danych na poziomie pacjenta, Danych na poziomie badania, Protokołu klinicznego i pełnego CSR, zapewniając dostęp do informacji z badania klinicznego zgodnie z zasadą ochrony poufnych informacji handlowych i pacjentów Prywatność. Wszelkie udostępniane dane na poziomie pacjenta są anonimizowane w celu ochrony danych osobowych.

Kryteria dostępu Chiesi i pełny proces udostępniania danych klinicznych są dostępne na stronie internetowej Grupy Chiesi.

Kryteria dostępu do udostępniania IPD

Kryteria dostępu Chiesi i pełny proces udostępniania danych klinicznych są dostępne na stronie internetowej Grupy Chiesi.

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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