Exhaled NO Based Treatment of Chronic Obstructive Pulmonary Disease (COPD), ICS/LABA Versus LAMA
9. september 2015 oppdatert av: Taipei Veterans General Hospital, Taiwan
The Treatment Effect of Inhaled Corticosteroid and Long-acting beta2 Agonist Combination Versus Long-acting Anti-cholinergic Agent on Stratified COPD Patients Based on the Levels of Exhaled Nitric Oxide
It is recognized that eosinophilic airway inflammation is more likely respond to steroid treatment.
However, in real-world practice, it is difficult to routinely assess airway inflammation using sputum induction because of technical and facility requirement.
COPD (chronic obstructive pulmonary disease) is a heterogeneous disease and it remains a great challenge to identify patients who have eosinophilic airway inflammation and respond to steroid treatment well.
A recent study demonstrated elevated plasma D-dimer was associated with acute inflammation and a significant predictor of pulmonary embolism in COPD exacerbated patients.
D-dimer may potentially act as a marker of inflammation and a predictor of cardiovascular event in COPD patients.
The investigators preliminary study demonstrated that exhaled nitric oxide (eNO) > 23.5 ppb is a good surrogate marker to predict eosinophilic airway inflammation in COPD patients who were newly diagnosed or untreated for at least 3 months.
There were significant correlations among sputum eosinophils, eNO and serum total immunoglobulin E (IgE).
Particularly, eNO predicted sputum eosinophilia (> 3%) in COPD at a sensitivity and specificity of 62% and 71% respectively.
Herein, the investigators test the hypothesis that eNO may act as a biomarker to determine treatment option for COPD.
Studieoversikt
Detaljert beskrivelse
Eligible COPD patients (newly diagnosed or untreated for at least 3 months) will be enrolled at out-patient clinic after consenting by participants.
Upon enrollment, exhaled NO (eNO) will be measured and patients will be categorized into 2 groups according to eNO levels: either high exhaled NO (greater than or equal to 23.5 ppb) or low eNO (< 23.5 ppb) group.
In each group, patients will be randomized to receive either 2 inhalations of fluticasone/salmeterol 250/25 mcg/ pudd twice daily or 2 inhalations of tiotropium 2.5 mcg/inhalation for 12 weeks and followed at scheduled visits.
Testing outcome measures include eNO, lung function, different count and mediators in induced sputum, and which will be tested as the following timings: before (baseline, week 0), and after treatment (week 4 and week 12).
Rescue medication and drug compliance will be record.
Studietype
Intervensjonell
Registrering (Forventet)
143
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Taipei City, Taiwan, 886
- Taipei Veterans General Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female outpatients aged from 40 to 90 years
- Current or ex-smoker, with smoking history ≧ 20 pack- years
- Newly diagnosed or untreated (at least 3 months) COPD patients (forced expiratory volume in first second (FEV1)/forced vital capacity (FVC) < 70%) with post-bronchodilator FEV1 < 80 % predicted value.
Exclusion Criteria:
- Concurrent allergic 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.
- Women with childbearing potential during the period of trial.
- Unable or unwilling to comply with all protocol
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: high eNO: ICS/LABA
patients with eNO >=23.5 ppb, receive inhaled corticosteroid (ICS)/long-acting beta2 agonist (ICS/LABA) of fluticasone/salmeterol 250/25 mcg/puff, 2 puffs bid.
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In group (either high or low eNO), patients will be randomized to receive either 2 puffs of fluticasone/salmeterol 250/25 mcg/puff twice daily or 2 inhalations of tiotropium respimat 2.5 mcg/inhalation once daily for 12 weeks.
Andre navn:
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Aktiv komparator: high eNO: LAMA
patients with eNO >=23.5 ppb, receive long acting muscarinic antagonist (LAMA) of tiotropium 2 inhalations 2.5 mcg/inhalation, once daily
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In group (either high or low eNO), patients will be randomized to receive either 2 puffs of fluticasone/salmeterol 250/25 mcg/puff twice daily or 2 inhalations of tiotropium respimat 2.5 mcg/inhalation once daily for 12 weeks.
Andre navn:
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Eksperimentell: Low eNO: ICS/LABA
patients with eNO < 23.5 ppb, receive fluticasone/salmeterol 250/25 mcg/puff, 2 puffs bid
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In group (either high or low eNO), patients will be randomized to receive either 2 puffs of fluticasone/salmeterol 250/25 mcg/puff twice daily or 2 inhalations of tiotropium respimat 2.5 mcg/inhalation once daily for 12 weeks.
Andre navn:
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Aktiv komparator: Low eNO: LAMA
patients with eNO < 23.5 ppb, receive tiotropium 2 inhalations 2.5 mcg/inhalation, once daily
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In group (either high or low eNO), patients will be randomized to receive either 2 puffs of fluticasone/salmeterol 250/25 mcg/puff twice daily or 2 inhalations of tiotropium respimat 2.5 mcg/inhalation once daily for 12 weeks.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Changes of eNO level
Tidsramme: Changes of eNO level (ppb) from baseline at 12 weeks
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Changes of eNO level (ppb) from baseline at 12 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Changes of lung function parameters (FEV1, FVC)
Tidsramme: Changes of lung function parameters (FEV1, FVC) from baseline at 12 weeks
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Changes of lung function parameters (FEV1, FVC) from baseline at 12 weeks
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Changes of serum level of IgE
Tidsramme: Changes of serum level of IgE (IU/ml) from baseline at 12 weeks
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Changes of serum level of IgE (IU/ml) from baseline at 12 weeks
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Changes of serum level of matrix metalloproteinase (MMP)-9
Tidsramme: Changes of serum level of MMP-9 (ng/ml) from baseline at 12 weeks
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Changes of serum level of MMP-9 (ng/ml) from baseline at 12 weeks
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Changes of serum level of D-dimer
Tidsramme: Changes of serum level of D-dimer (ug/ml) from baseline at 12 weeks
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Changes of serum level of D-dimer (ug/ml) from baseline at 12 weeks
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Changes of scales of life quality questionnaire
Tidsramme: Changes of scales of life quality questionnaire from baseline at 12 weeks
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COPD assessment test (CAT)
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Changes of scales of life quality questionnaire from baseline at 12 weeks
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Changes of proportion of cell counts in induced sputum
Tidsramme: Changes of proportion of cell counts in induced sputum from baseline at 12 weeks
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Changes of proportion of cell counts in induced sputum from baseline at 12 weeks
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Changes of MMP-9 level in induced sputum
Tidsramme: Changes of MMP-9 levle (ug/ml) in induced sputum from baseline at 12 weeks
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Changes of MMP-9 levle (ug/ml) in induced sputum from baseline at 12 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studiestol: Diahn-Warng S Perng, PhD, Taipei Veterans General Hospital, Taiwan
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2014
Primær fullføring (Forventet)
1. desember 2015
Studiet fullført (Forventet)
1. januar 2016
Datoer for studieregistrering
Først innsendt
25. februar 2015
Først innsendt som oppfylte QC-kriteriene
9. september 2015
Først lagt ut (Anslag)
10. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. september 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2015
Sist bekreftet
1. september 2015
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
- Parasympatholytika
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Kolinerge antagonister
- Kolinerge midler
- 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
- Salmeterol Xinafoate
- Flutikason-salmeterol medikamentkombinasjon
- Tiotropiumbromid
Andre studie-ID-numre
- 140420
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