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Ztrojnásobek u astmatu s nekontrolovaným pacientem se střední intenzitou IKS + LABA (TRIMARAN)

2. června 2026 aktualizováno: Chiesi Farmaceutici S.p.A.

52 TÝDENNÍ, RANDOMIZOVANÁ, DVOJITÁ SLEPÁ, MULTINACIONÁLNÍ, MULTICENTROVÁ, AKTIVNĚ ŘÍZENÁ, 2-RAMENOVÁ PARALELNÍ SKUPINOVÁ ZKOUŠKA POROVNÁVAJÍCÍ CHF 5993 100/6/12,5 µg pMDI (Pevná KOMBINACE EXTRAFINE BECLOMETIONATE1 52,5 µg PMDI TOHLEUMDI) /6 µg pMDI (Pevná KOMBINACE EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) U PACIENTŮ S ASTMA NEKONTROLOVANÝM STŘEDNÍMI DÁVKAMI INHALAČNÍCH KORTIKOSTEROIDŮ V KOMBINACI S DLOUHODOBĚ PŮSOBÍCÍM ß2 AGONISTEM

Účelem této studie je vyhodnotit nadřazenost CHF 5993 100/6/12,5 µg pMDI (fixní kombinace extra jemného beklometason dipropionátu plus formoterol fumarát plus glykopyrronium bromid) versus CHF 1535 100/6 µg pMDI (fixní kombinace extra jemného beklometason dipropionátu plus formoterol fumarát), pokud jde o funkce plic a exacerbace jako parametry a rychlost exacerbací k posouzení jeho bezpečnosti a některých zdravotně ekonomických výsledků.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

1155

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  • Anamnéza astmatu ≥ 1 rok a diagnostikovaná před 40. rokem věku
  • Nekontrolované astma s dvojitou terapií pouze středními dávkami inhalačního kortikosteroidu (ICS) v kombinaci s dlouhodobě působícím beta2 agonistou (LABA) s ACQ-7 (Asthma Control Questionnaire) ≥1,5
  • FEV1 před bronchodilatací < 80 % předpokládané normální hodnoty
  • Pozitivní test reverzibility
  • Alespoň 1 zdokumentovaná exacerbace astmatu v předchozím roce

Kritéria vyloučení:

  • Těhotné nebo kojící ženy
  • Diagnostika chronické obstrukční plicní nemoci (CHOPN)
  • Pacienti s jakoukoli exacerbací astmatu nebo infekcí dýchacích cest během 4 týdnů před screeningem
  • Současní nebo bývalí kuřáci (>= 10 balení za rok)
  • Jakákoli změna v dávce, schématu nebo formulaci kombinace IKS + LABA během 4 týdnů před screeningem

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Lék: CHF 5993 100/6/12.5
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg; GB=Glycopyrronium Bromide 12.5µg.
Aktivní komparátor: 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
Lék: CHF 1535 100/6 µg
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Nežádoucí účinky a nežádoucí reakce na léky
Časové okno: Až do 52. týdne
Až do 52. týdne
Sborník výstupů Health Economics
Časové okno: Týden 0 až 52
Úplné využití zdrojů zdravotní péče a nepřítomnost v práci
Týden 0 až 52

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Chiesi Farmaceutici S.p.A.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Christian Virchow, MD, Facharzt für Innere Medizin Rostock, Germany

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. února 2016

Primární dokončení (Aktuální)

17. května 2018

Dokončení studie (Aktuální)

17. května 2018

Termíny zápisu do studia

První předloženo

3. února 2016

První předloženo, které splnilo kritéria kontroly kvality

3. února 2016

První zveřejněno (Odhadovaný)

8. února 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Chiesi se zavazuje sdílet s kvalifikovanými vědeckými a lékařskými výzkumníky, provádět legitimní výzkum, údaje na úrovni pacienta, údaje na úrovni studie, klinický protokol a úplné CSR, poskytovat přístup k informacím z klinických studií v souladu se zásadou ochrany komerčně důvěrných informací a informací o pacientovi Soukromí. Jakákoli sdílená data na úrovni pacienta jsou anonymizována, aby byly chráněny osobní údaje.

Přístupová kritéria Chiesi a kompletní proces sdílení klinických dat jsou k dispozici na webových stránkách Chiesi Group.

Kritéria přístupu pro sdílení IPD

Přístupová kritéria Chiesi a kompletní proces sdílení klinických dat jsou k dispozici na webových stránkách Chiesi Group.

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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