14729-D9831C00002- 1 Month Biopsy Study (Biopsy)
27. januar 2014 oppdatert av: AstraZeneca
A Double-blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
52
Fase
- Fase 2
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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Amsterdam, Nederland
- Research Site
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Leicester, Storbritannia
- Research Site
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London, Storbritannia
- Research Site
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Manchester, Storbritannia
- Research Site
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Newcastle upon Tyne, Storbritannia
- Research Site
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Frieburg, Tyskland
- Research Site
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GROßHANSDORF, Tyskland
- Research Site
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Hannover, Tyskland
- Research Site
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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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Men or women 40 years or above
- FEV1 between 40 and 80% of predicted normal value post-bronchodilator
- Clinical diagnosis of COPD
Exclusion Criteria:
- Other clinically relevant disease or disorders
- Exacerbation of COPD within 30 days
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: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Placebo
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Placebo
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Eksperimentell: AZD1981
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Oral tablet, twice daily, 4 weeks treatment
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Aggregated Pathology Score
Tidsramme: Before and after 1 month treatment
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Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts.
Each subscore measured on scale 1 (normal) to 5 (worst outcome).
Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome).
Change from baseline.
|
Before and after 1 month treatment
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Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
Tidsramme: Before and after 1 month treatment
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Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
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Before and after 1 month treatment
|
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Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
Tidsramme: Before and after 1 month treatment
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Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
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Before and after 1 month treatment
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Bronchoalveolar Lavage (BAL): Macrophages Count (%)
Tidsramme: Before and after 1 month treatment
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Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
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Before and after 1 month treatment
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Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
Tidsramme: Before and after 1 month treatment
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Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
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Before and after 1 month treatment
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Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
Tidsramme: Before and after 1 month treatment
|
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
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Before and after 1 month treatment
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Bronchoalveolar Lavage (BAL): Total Cells Count
Tidsramme: Before and after 1 month treatment
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Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
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Before and after 1 month treatment
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Induced Sputum: Eosinophil Count (%)
Tidsramme: Before and after 3 week treatment
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Change in Induced sputum Eosinophil count (% of total) from baseline
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Before and after 3 week treatment
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Induced Sputum: Neutrophils Count (%)
Tidsramme: Before and after 3 week treatment
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Change in Induced sputum Neutrophils count (% of total) from baseline
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Before and after 3 week treatment
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Induced Sputum: Macrophages Count (%)
Tidsramme: Before and after 3 week treatment
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Change in Induced sputum Macrophages count (% of total) from baseline
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Before and after 3 week treatment
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Induced Sputum: Lymphocytes Count (%)
Tidsramme: Before and after 3 week treatment
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Change in Induced sputum Lymphocytes count (% of total) from baseline
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Before and after 3 week treatment
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Induced Sputum: Epithelial Cells Count (%)
Tidsramme: Before and after 3 week treatment
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Change in Induced sputum Epithelial cells count (% of total) from baseline
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Before and after 3 week treatment
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Induced Sputum: Total Cells Count
Tidsramme: Before and after 3 week treatment
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Change in Induced sputum Total cells count from baseline
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Before and after 3 week treatment
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: Before and after 1 month treatment
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Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment
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Before and after 1 month treatment
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Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)
Tidsramme: Before and after 1 month treatment
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Change in total CCQ score from baseline to last measurement on treatment.
scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)
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Before and after 1 month treatment
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Peak Expiratory Flow (PEF) Morning
Tidsramme: Before and after 1 month treatment
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Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period
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Before and after 1 month treatment
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Peak Expiratory Flow (PEF) Evening
Tidsramme: Before and after 1 month treatment
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Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period
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Before and after 1 month treatment
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Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score
Tidsramme: Before and after 1 month treatment
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Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period.
0=(no symptom)-4=(no sleep)
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Before and after 1 month treatment
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Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score
Tidsramme: Before and after 1 month treatment
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Mean change in COPD symptom breathing score from baseline to the average of the treatment period.
0= (none) - 4 =(severe).
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Before and after 1 month treatment
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Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score
Tidsramme: Before and after 1 month treatment
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Mean change in COPD symptom cough score from baseline to the average of the treatment period.
0= (none) - 4= (almost constant)
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Before and after 1 month treatment
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Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score
Tidsramme: Before and after 1 month treatment
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Mean change in COPD symptom sputum score from baseline to the average of the treatment period.
0= (none) - 4= (severe).
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Before and after 1 month treatment
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Adverse Event (AE)
Tidsramme: 1 month
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Number of participants with an Adverse Event
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1 month
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Norbert Krug, Fraunhofer Institute
Publikasjoner og nyttige lenker
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Hjelpsomme linker
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. november 2008
Studiet fullført (Faktiske)
1. juni 2009
Datoer for studieregistrering
Først innsendt
3. oktober 2008
Først innsendt som oppfylte QC-kriteriene
3. oktober 2008
Først lagt ut (Anslag)
6. oktober 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. februar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. januar 2014
Sist bekreftet
1. januar 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D9831C00002
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