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TRIple bij astma met ongecontroleerde patiënt op gemiddelde sterkte van ICS + LABA (TRIMARAN)

2 juni 2026 bijgewerkt door: Chiesi Farmaceutici S.p.A.

EEN 52 WEEK, GERANDOMISEERDE, DUBBELBLINDE, MULTINATIONALE, MULTICENTRE, ACTIEF GECONTROLEERDE, 2-ARME PARALLELLE GROEPSPROEF VERGELIJKING CHF 5993 100/6/12,5 µg pMDI (VASTE COMBINATIE VAN EXTRAFINE BECLOMETASONE DIPROPIONAAT PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE53) MET CHF 1053 /6 µg pMDI (VASTE COMBINATIE VAN EXTRAFINE BECLOMETHASONE DIPROPIONAAT PLUS FORMOTEROL FUMARATE) BIJ PATIËNTEN MET ASTMA ONGECONTROLEERD MET EEN GEMIDDELDE DOSERING VAN GEÏNHALEERDE CORTICOSTEROÏDEN IN COMBINATIE MET LANGWERKENDE ß2-AGONISTEN

Het doel van deze studie is om de superioriteit van CHF 5993 100/6/12,5 te evalueren µg pMDI (vaste combinatie van extrafijn beclometasondipropionaat plus formoterolfumaraat plus glycopyrronumbromide) versus CHF 1535 100/6 µg pMDI (vaste combinatie van extrafijn beclometasondipropionaat plus formoterolfumaraat), in termen van longfunctieparameters en snelheid van exacerbaties, evenals om de veiligheid en enkele gezondheidseconomische resultaten te beoordelen.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1155

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  • Geschiedenis van astma ≥ 1 jaar en gediagnosticeerd vóór 40 jaar oud
  • Ongecontroleerd astma met dubbele therapie alleen bij middelmatige doses inhalatiecorticosteroïde (ICS) in combinatie met langwerkende bèta2-agonist (LABA) met ACQ-7 (Astma Control Questionnaire) ≥1,5
  • Pre-bronchusverwijder FEV1 <80% van de voorspelde normale waarde
  • Positieve reversibiliteitstest
  • Minstens 1 gedocumenteerde astma-exacerbatie in het voorgaande jaar

Uitsluitingscriteria:

  • Zwangere of zogende vrouwen
  • Diagnose van chronische obstructieve longziekte (COPD)
  • Patiënten met een astma-exacerbatie of luchtweginfectie in de 4 weken voorafgaand aan de screening
  • Huidige of ex-rokers (>= 10 pakjes jaar)
  • Elke wijziging in dosis, schema of formulering van de ICS + LABA-combinatie in de 4 weken voorafgaand aan de screening

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Geneesmiddel: CHF 5993 100/6/12.5
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg; GB=Glycopyrronium Bromide 12.5µg.
Actieve vergelijker: 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
Geneesmiddel: CHF 1535 100/6 µg
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Bijwerkingen en bijwerkingen van geneesmiddelen
Tijdsspanne: Tot week 52
Tot week 52
Verzameling van gezondheidseconomische uitkomsten
Tijdsspanne: Week 0 tot week 52
Totaal gebruik van zorgmiddelen en ziekteverzuim
Week 0 tot week 52

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chiesi Farmaceutici S.p.A.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 februari 2016

Primaire voltooiing (Werkelijk)

17 mei 2018

Studie voltooiing (Werkelijk)

17 mei 2018

Studieregistratiedata

Eerst ingediend

3 februari 2016

Eerst ingediend dat voldeed aan de QC-criteria

3 februari 2016

Eerst geplaatst (Geschat)

8 februari 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Chiesi verbindt zich ertoe om gegevens op patiëntniveau, gegevens op studieniveau, het klinische protocol en de volledige CSR te delen met gekwalificeerde wetenschappelijke en medische onderzoekers, die legitiem onderzoek uitvoeren, en toegang te bieden tot informatie over klinische onderzoeken, in overeenstemming met het principe van het beschermen van commercieel vertrouwelijke informatie en patiëntgegevens. privacy. Alle gedeelde gegevens op patiëntniveau worden geanonimiseerd om persoonlijk identificeerbare informatie te beschermen.

Chiesi-toegangscriteria en het volledige proces voor het delen van klinische gegevens zijn beschikbaar op de Chiesi Group-website.

IPD-toegangscriteria voor delen

Chiesi-toegangscriteria en het volledige proces voor het delen van klinische gegevens zijn beschikbaar op de Chiesi Group-website.

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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