Exhaled NO Based Treatment of Chronic Obstructive Pulmonary Disease (COPD), ICS/LABA Versus LAMA
9 september 2015 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
143
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Taipei City, Taiwan, 886
- Taipei Veterans General Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
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
|
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.
Andra namn:
|
|
Experimentell: Low eNO: ICS/LABA
patients with eNO < 23.5 ppb, receive fluticasone/salmeterol 250/25 mcg/puff, 2 puffs bid
|
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.
Andra namn:
|
|
Aktiv komparator: Low eNO: LAMA
patients with eNO < 23.5 ppb, receive tiotropium 2 inhalations 2.5 mcg/inhalation, once daily
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Changes of eNO level
Tidsram: Changes of eNO level (ppb) from baseline at 12 weeks
|
Changes of eNO level (ppb) from baseline at 12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes of lung function parameters (FEV1, FVC)
Tidsram: Changes of lung function parameters (FEV1, FVC) from baseline at 12 weeks
|
Changes of lung function parameters (FEV1, FVC) from baseline at 12 weeks
|
|
|
Changes of serum level of IgE
Tidsram: Changes of serum level of IgE (IU/ml) from baseline at 12 weeks
|
Changes of serum level of IgE (IU/ml) from baseline at 12 weeks
|
|
|
Changes of serum level of matrix metalloproteinase (MMP)-9
Tidsram: Changes of serum level of MMP-9 (ng/ml) from baseline at 12 weeks
|
Changes of serum level of MMP-9 (ng/ml) from baseline at 12 weeks
|
|
|
Changes of serum level of D-dimer
Tidsram: Changes of serum level of D-dimer (ug/ml) from baseline at 12 weeks
|
Changes of serum level of D-dimer (ug/ml) from baseline at 12 weeks
|
|
|
Changes of scales of life quality questionnaire
Tidsram: Changes of scales of life quality questionnaire from baseline at 12 weeks
|
COPD assessment test (CAT)
|
Changes of scales of life quality questionnaire from baseline at 12 weeks
|
|
Changes of proportion of cell counts in induced sputum
Tidsram: Changes of proportion of cell counts in induced sputum from baseline at 12 weeks
|
Changes of proportion of cell counts in induced sputum from baseline at 12 weeks
|
|
|
Changes of MMP-9 level in induced sputum
Tidsram: Changes of MMP-9 levle (ug/ml) in induced sputum from baseline at 12 weeks
|
Changes of MMP-9 levle (ug/ml) in induced sputum from baseline at 12 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studiestol: Diahn-Warng S Perng, PhD, Taipei Veterans General Hospital, Taiwan
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2014
Primärt slutförande (Förväntat)
1 december 2015
Avslutad studie (Förväntat)
1 januari 2016
Studieregistreringsdatum
Först inskickad
25 februari 2015
Först inskickad som uppfyllde QC-kriterierna
9 september 2015
Första postat (Uppskatta)
10 september 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 september 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 september 2015
Senast verifierad
1 september 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Lungsjukdomar
- Lungsjukdomar, obstruktiv
- Lungsjukdom, kronisk obstruktiv
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Parasympatholytika
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Kolinerga antagonister
- Kolinerga medel
- Antiinflammatoriska medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Adrenerga agonister
- Dermatologiska medel
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Anti-allergiska medel
- Adrenerga beta-2-receptoragonister
- Adrenerga beta-agonister
- Sympatomimetika
- Flutikason
- Salmeterol Xinafoate
- Flutikason-salmeterol läkemedelskombination
- Tiotropiumbromid
Andra studie-ID-nummer
- 140420
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .