- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01131806
Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients
Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and the use of health care resources worldwide. It is characterized by chronic progressive symptoms, airflow obstruction, and impaired health status, which is worse in those who have frequent, acute episodes of symptom exacerbation. Treatment for COPD is focused on minimizing risk factors, improving symptoms, and preventing exacerbations.
Pulmonary inflammation is the key factor in COPD. Inhaled long-acting β2 agonists (LABA) improve airflow obstruction, control of symptoms, and health status in patients with COPD over 3 to 4 months. Inhaled corticosteroids (ICS) are currently the most popular anti-inflammatory medications for use in symptomatic patients with COPD. Previous large scaled randomized control study discovered long-term use of ICS didn't modified annual decline of lung function in COPD patients, but may reduce the frequency of exacerbations, especially when combined with an LABA.
Combination treatment with ICS and LABA has been widely used for patients with COPD and attains an improved control of symptoms and lung function, with no greater risk of side-effects than that of treatment with either component alone. Combined ICS/LABA will result in better treatment effects that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
Studietype
Registrering (Forventet)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Diahn-Warng Perng, PhD
- Telefonnummer: 3194 +886-2-28712121
- E-post: dwperng@vghtpe.gov.tw
Studer Kontakt Backup
- Navn: Kang-Cheng Su, MD
- Telefonnummer: 8928 +886-2-28712121
- E-post: kcsu@vghtpe.gov.tw
Studiesteder
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-
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Taipei City, Taiwan, 112
- Rekruttering
- Chest department, Veteran General Hospital-TAIPEI
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Ta kontakt med:
- Diahn-Warng Perng, PhD
- Telefonnummer: 3194 +886-2-28712121
- E-post: dwperng@vghtpe.gov.tw
-
Ta kontakt med:
- Kang-Cheng Su, MD
- Telefonnummer: 8928 +886-2-28712121
- E-post: kcsu@vghtpe.gov.tw
-
Underetterforsker:
- Kang-Cheng Su, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male or female outpatients aged ≧ 40 years.
- Current or ex-smoker, with smoking history ≧ 10 pack- years
- COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 ≦ 70% predicted value, without bronchial reversibility (≦10% increase post bronchodilator).
Exclusion Criteria:
- Diagnosis or suspicion of sleep apnea
- Concurrent rhinitis, eczema, and asthma
- Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease
- A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
- Major disease abnormalities are uncontrolled on therapy.
- Alcohol or medication abuse.
- Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
- Unable or unwilling to comply with all protocol specified procedures.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: MD Flu/Sal
fluticasone125 mcg/ salmeterol 25 mcg 2puffs (medium dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.
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fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
Andre navn:
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Eksperimentell: HD Flu/Sal
fluticasone 250 mcg/salmeterol 25 mcg 2puffs (high dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.
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fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The change of lung function parameters(FEV1&FVC) at different time points
Tidsramme: baseline, week 12, 28 and 52
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The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), at different time points, including baseline, 12th week, 28th week, and ending (52th week).
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baseline, week 12, 28 and 52
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Annual rate of acute exacerbations
Tidsramme: 1 year
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total numbers of acute exacerbation throughout the study year
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1 year
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Life quality evaluation
Tidsramme: baseline, week 12, 28, and 52
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The changes of Health-related quality of life assessed by CAT questionnaire before and after treatment.
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baseline, week 12, 28, and 52
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Annual incidence of community-acquired pneumonia
Tidsramme: 1 year
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Annual incidence of community-acquired pneumonia throughout the study year
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1 year
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Diahn-Warng Perng, PhD, Taipei Veterans General Hospital, Taiwan
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775-89. doi: 10.1056/NEJMoa063070.
- Keating GM, McCormack PL. Salmeterol/fluticasone propionate: a review of its use in the treatment of chronic obstructive pulmonary disease. Drugs. 2007;67(16):2383-405. doi: 10.2165/00003495-200767160-00006.
- Hanania NA, Darken P, Horstman D, Reisner C, Lee B, Davis S, Shah T. The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest. 2003 Sep;124(3):834-43. doi: 10.1378/chest.124.3.834.
- Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, Peterson S, Olsson H. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J. 2003 Jan;21(1):74-81. doi: 10.1183/09031936.03.00031402. Erratum In: Eur Respir J. 2003 May;21(5):912.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Lungesykdommer
- Lungesykdommer, obstruktiv
- Lungesykdom, kronisk obstruktiv
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Anti-inflammatoriske midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Adrenerge agonister
- Dermatologiske midler
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Anti-allergiske midler
- Adrenerge beta-2-reseptoragonister
- Adrenerge beta-agonister
- Sympatomimetikk
- Flutikason
- Xhance
- Salmeterol Xinafoate
- Flutikason-salmeterol medikamentkombinasjon
Andre studie-ID-numre
- VGHIRB No. 98-10-16
- CM981016 (Annen identifikator: Veterans General Hospital-TAIPEI)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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