- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02941679
Clinical Efficacy and Safety Evaluation of HCP1202 in COPD Patients
19. oktober 2016 opdateret af: Hanmi Pharmaceutical Company Limited
A 24-week, Randomized, Double-Blind, Active-controlled, Parallel Study of HCP1202 Combination Product, HGP1011, and HCP0910 in Treatment of Subjects With COPD
A phase 3 study to evaluate efficacy and safety of HCP1202
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial to evaluate the efficacy and safety of HCP1202 compared to either treatment with HGP1011 or HCP0910 in COPD patients.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
252
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or Female adults aged ≥ 40 years.
- Patients diagnosed with COPD.
- Patients with FEV1/FVC < 0.7 at screening.
- Patients with a post-bronchodilator FEV1 < 60% of the predicted normal OR Patients with a post-bronchodilator FEV1 < 80% of the predicted normal if COPD exacerbation is moderate or worse developed at least twice within the past year or hospitalization occurred at least once within the past year due to COPD exacerbation.
- Patients with COPD Assessment Test ≥ 10.
- Patients with a history (current or ex-smokers) of smoking 10 pack-years or more (e.g. 10 pack years = 1 pack/day x 10 years, or ½ pack/day x 20 years).
- Patients who understand the process of clinical trial and signed written informed consent.
Exclusion Criteria:
- Patients with a current diagnosis of asthma.
- Patients with the following lung disorders that can affect the clinical trial, except for COPD: lung cancer, interstitial lung disease, thromboembolic pulmonary disease, moderate to severe bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, active tuberculosis, clinically significant tuberculous destroyed lung, alpha1-antitrypsin deficiency, etc.
- Patients underwent pulmonary lobectomy or lung volume reduction surgery within the past year.
- Patients who developed COPD exacerbation where antibiotics and/or systemic corticosteroids and/or hospitalization is advisable within 4 weeks prior to Visit 1 or during Run-in period (but, re-screening is possible 4 weeks after resolution of the COPD exacerbation occurred within 4 weeks prior to Visit 1).
- Patients who administered antibiotics for lower respiratory infection within 4 weeks prior to Visit 1 or during Run-in period (but, re-screening is possible 4 weeks after resolution of COPD exacerbation occurred within 4 weeks prior to Visit 1).
- Patients who have changed the COPD treatment method within 12 weeks prior to Visit 1 (but, PDE4 inhibitor can be used until 4 weeks prior to Visit 1).
- Patients administered systemic corticosteroids within 4 weeks prior to Visit 1.
- Patients with the following clinically significant cardiovascular diseases: a history of myocardial infarction or unstable angina within 6 months prior to Visit 1, a history of unstable arrhythmia where its therapy method has been changed within 1 year prior to Visit 1, a history of hospitalization from NYHA Class III-IV heart failure, a history of atrial fibrillation, negative cardiac tachycardia, and/or hypertrophic cardiomyopathy.
- Patients with a history of long QTc syndrome.
- Patients with the clinical significance of ECG abnormality at screening (QTc(F) ≥ 470 ms).
- Patients who require long-term oxygen therapy for more than 12 hours a day.
- Patients participated in acute respiratory rehabilitation within 6 months prior to Visit 1 (except for the patients under stabilized respiratory rehabilitation therapy of at least 6 weeks).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: HCP1202
Test
|
Hanmi Pharmaceutical.
Co., Ltd.
Andre navne:
|
Aktiv komparator: HGP1011
Control
|
Boehringer Ingelheim
Andre navne:
|
Aktiv komparator: HCP0910
Control
|
GlaxoSmithKline
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from Baseline in Trough FEV1 at Week 12
Tidsramme: Baseline, Week 12
|
Baseline, Week 12
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from Baseline in Trough FEV1 at Week 4 & 8
Tidsramme: Baseline, Week 4, Week 8
|
Baseline, Week 4, Week 8
|
Change from Baseline in Trough FVC at Week 4 & 8 & 12
Tidsramme: Baseline, Week 4, Week 8, Week 12
|
Baseline, Week 4, Week 8, Week 12
|
Change from Baseline in Trough FEV1/FVC at Week 4 & 8 & 12
Tidsramme: Baseline, Week 4, Week 8, Week 12
|
Baseline, Week 4, Week 8, Week 12
|
Transition Dyspnea Index scores at Week 4 & 8 & 12
Tidsramme: Week 4, Week 8, Week 12
|
Week 4, Week 8, Week 12
|
Change from Baseline in Total SGRQ-C (St. George's Respiratory Questionnaire for COPD patients) and sectional scores at Week 4 & 8 & 12
Tidsramme: Baseline, Week 4, Week 8, Week 12
|
Baseline, Week 4, Week 8, Week 12
|
Percentage (%) of Subjects Experienced with Moderate to Severe COPD Exacerbation from Baseline to Week 12
Tidsramme: Baseline through Week 12
|
Baseline through Week 12
|
Number of Occurrences in Moderate to Severe COPD Exacerbation per Subject from Baseline to Week 12
Tidsramme: Baseline through Week 12
|
Baseline through Week 12
|
Total Amount of Rescue Medication Used per Subject from Baseline to Week 12
Tidsramme: Baseline through Week 12
|
Baseline through Week 12
|
Average Daily Use of Rescue Medication per Subject from Baseline to Week 12
Tidsramme: Baseline through Week 12
|
Baseline through Week 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: HyoungKyu Yoon, M.D., Ph.D., Yeouido St. Mary's Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2016
Primær færdiggørelse (Forventet)
1. februar 2018
Studieafslutning (Forventet)
1. april 2018
Datoer for studieregistrering
Først indsendt
14. oktober 2016
Først indsendt, der opfyldte QC-kriterier
19. oktober 2016
Først opslået (Skøn)
21. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HM-FLUT-301
Plan for individuelle deltagerdata (IPD)
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