Tredobbelt i astMA med ukontrolleret patient på medium styrke af ICS + LABA (TRIMARAN)
ET 52 UGERS, RANDOMISERET, DOBBELT BLINDT, MULTINATIONAL, MULTICENTRET, AKTIVT KONTROLLERET, 2-ARMET PARALLEL GRUPPE FORSØG SOM SAMMENLIGNER CHF 5993 100/6/12,5 µg pMDI (FAST KOMBINATION AF EKSTRAFIN BEDIKRONAT 5993 100/6/12,5 µg pMDI (FAST KOMBINATION AF EKSTRAFIN BEDIKRONAT TIL 5 PLUS 1 /6 µg pMDI (FAST KOMBINATION AF EKSTRAFIN BECLOMETHASONE DIPROPIONAT PLUS FORMOTEROL FUMARAT) HOS PATIENTER MED ASTHMA UKONTROLLERET PÅ MELLEMDOSER AF INHALERENDE KORTIKOSTEROIDER I KOMBINATION MED LANG AKTIVERING
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Rostock, Tyskland
- Chiesi Clinical Trial Site 276814
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Anamnese med astma ≥ 1 år og diagnosticeret før 40 år
- Ukontrolleret astma med dobbeltbehandling kun på mellemdoser af inhaleret CorticoSteroid (ICS) i kombination med langtidsvirkende beta2-agonist (LABA) med ACQ-7 (Asthma Control Questionnaire) ≥1,5
- Pre-bronkodilatator FEV1 <80 % af den forudsagte normalværdi
- Positiv reversibilitetstest
- Mindst 1 dokumenteret astmaforværring i det foregående år
Ekskluderingskriterier:
- Gravide eller ammende kvinder
- Diagnose af kronisk obstruktiv lungesygdom (KOL)
- Patienter med enhver astmaeksacerbation eller luftvejsinfektion i de 4 uger forud for screening
- Nuværende eller tidligere rygere (>= 10 pakker år)
- Enhver ændring i dosis, tidsplan eller formulering af ICS + LABA kombination i de 4 uger forud for screening
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: 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 |
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg; GB=Glycopyrronium Bromide 12.5µg.
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Aktiv 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 |
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Tidsramme: Week 0 (pre-treatment, baseline) to Week 26.
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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.
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2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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:
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Week 0 (pre-treatment, baseline) to Week 52.
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
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Week 0 (pre-treatment, baseline) to Week 52.
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3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
Tidsramme: Week 0 (pre-treatment, baseline) and Week 26.
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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.
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4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
Tidsramme: Week 0 (pre-treatment, baseline) to Week 26.
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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.
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5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
Tidsramme: The entire treatment period; up to Week 52.
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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.
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6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in pre-dose FEV1 at all clinical visits.
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Week 0 (pre-treatment, baseline) to Week 52.
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8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
Tidsramme: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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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.
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Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
Tidsramme: Week 0 (pre-treatment, baseline) to Week 26 and Week 52
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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
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12a_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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12b_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
Tidsramme: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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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.
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13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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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
Tidsramme: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
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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.
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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.
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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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
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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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
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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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
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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Moderate asthma exacerbation rate over the 52-Week treatment period.
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Week 0 (pre-treatment, baseline) to Week 52.
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21a_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
Tidsramme: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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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.
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21b_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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22a_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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22b_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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23a_Change From Baseline in the Average Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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Week 0 (pre-treatment, baseline) to Week 52.
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23b_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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Week 0 (pre-treatment, baseline) to Week 52.
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24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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24b_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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25a_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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25b_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
Tidsramme: Week 0 (pre-treatment, baseline) to Week 52.
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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.
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Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Uønskede hændelser og bivirkninger
Tidsramme: Op til uge 52
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Op til uge 52
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Samling af sundhedsøkonomiske resultater
Tidsramme: Uge 0 til uge 52
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Samlet brug af sundhedsressourcer og fravær fra arbejde
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Uge 0 til uge 52
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Christian Virchow, MD, Facharzt für Innere Medizin Rostock, Germany
Publikationer og nyttige links
Generelle publikationer
- Virchow JC, Kuna P, Paggiaro P, Papi A, Singh D, Corre S, Zuccaro F, Vele A, Kots M, Georges G, Petruzzelli S, Canonica GW. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019 Nov 9;394(10210):1737-1749. doi: 10.1016/S0140-6736(19)32215-9. Epub 2019 Sep 30.
- Orlovic M, Magni T, Lukyanov V, Guerra I, Madoni A. Cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium in patients with uncontrolled asthma in England. Respir Med. 2022 Sep;201:106934. doi: 10.1016/j.rmed.2022.106934. Epub 2022 Jul 19.
- Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER. Respir Res. 2020 Oct 29;21(1):285. doi: 10.1186/s12931-020-01558-y.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Extrafine triple therapy in patients with asthma and persistent airflow limitation. Eur Respir J. 2020 Sep 24;56(3):2000476. doi: 10.1183/13993003.00476-2020. Print 2020 Sep. No abstract available.
- Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Hjælpsomme links
- Study Record on EU Clinical Trials Register including results.
- Study Record on EU Clinical Trials Register including results. Study CCD-05993AB2-02; TRIGGER;
- TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA (TRIMARAN) ClinicalTrials.gov ID NCT02676076
- Time course of exacerbation reduction with extrafine beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) pMDI in adults with moderate to severe asthma: A post-hoc analysis of the TRIMARAN and TRIGGER Studies
- TRIple in Asthma hiGh strenGth vErsus Ics/ Laba hs and tiotRopium (TRIGGER)
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CCD-05993AB1-03
- 2015-000716-18 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Chiesi forpligter sig til at dele med kvalificerede videnskabelige og medicinske forskere, udføre legitim forskning, data på patientniveau, data på undersøgelsesniveau, den kliniske protokol og den fulde CSR, give adgang til oplysninger om kliniske forsøg i overensstemmelse med princippet om at beskytte kommercielt fortrolige oplysninger og patient privatliv. Alle delte data på patientniveau anonymiseres for at beskytte personligt identificerbare oplysninger.
Chiesi adgangskriterier og komplet proces for klinisk datadeling er tilgængelig på Chiesi Groups hjemmeside.
IPD-delingsadgangskriterier
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .