Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (TOP)
4 november 2010 uppdaterad av: AstraZeneca
A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
65
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Hvidovre, Danmark
- Research Site
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København Nv, Danmark
- Research Site
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Odense C, Danmark
- Research Site
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Helsinki, Finland
- Research Site
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Preitilä, Finland
- Research Site
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Tampere, Finland
- Research Site
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Breda, Nederländerna
- Research Site
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Groningen, Nederländerna
- Research Site
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Elverum, Norge
- Research Site
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Oslo, Norge
- Research Site
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Trondheim, Norge
- Research Site
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Lund, Sverige
- Research Site
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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 och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Clinical diagnosis of COPD, with symptoms for more than 1 year
- Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
- Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator
Exclusion Criteria:
- Clinical suspicion of active tuberculosis
- Any current clinically significant respiratory tract disorder other than COPD
- History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
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: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: 2
Placebo
|
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Experimentell: 1
AZD4818
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Dry Powder, inhalation, b.i.d., 4 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Patients Experiencing Adverse Events
Tidsram: At all study visits
|
Number of patients who had an Adverse Event
|
At all study visits
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Forced Expiratory Volume 1 (FEV1)
Tidsram: Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
Change in (FEV1) from baseline to end of treatment
|
Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
|
Forced Vital Capacity (FVC)
Tidsram: Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
Change in FVC from baseline to end of treatment
|
Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
|
Vital Capacity (VC)
Tidsram: Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
Change in VC from baseline to end of treatment
|
Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
|
Inspiratory Capacity (IC)
Tidsram: Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
Change from IC baseline to end of treatment
|
Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
|
Forced Expiratory Flow (FEF) 25%-75%
Tidsram: Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
Change in FEF from baseline to end of treatment
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Before treatment and after 1, 2, 3 and 4 weeks of treatment
|
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Peak Expiratory Flow (PEF) Morning
Tidsram: Daily during run-in and treatment
|
Change from average during run-in to average during treatment
|
Daily during run-in and treatment
|
|
Peak Expiratory Flow (PEF) Evening
Tidsram: Daily during run-in and treatment
|
Change in PEF from average during run-in to average during treatment
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Daily during run-in and treatment
|
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The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total
Tidsram: Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)
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Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Tidsram: Daily during run-in and treatment
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Change from average during run-in to average during treatment.
Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
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Daily during run-in and treatment
|
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Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Tidsram: Daily during run-in and treatment
|
Change from average during run-in to average during treatment.
Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
|
Daily during run-in and treatment
|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Tidsram: Daily during run-in and treatment
|
Change from average during run-in to average during treatment.
Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
|
Daily during run-in and treatment
|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
Tidsram: Daily during run-in and treatment
|
Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
|
Daily during run-in and treatment
|
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6-minute Walk Test
Tidsram: Before treatment and after 4 weeks of treatment
|
Change from baseline to end of treatment
|
Before treatment and after 4 weeks of treatment
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Huib AM Kerstjens, MD, PhD, University Medical Centre, Groningen, The Netherlands
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 januari 2008
Primärt slutförande (Faktisk)
1 juni 2008
Avslutad studie (Faktisk)
1 augusti 2008
Studieregistreringsdatum
Först inskickad
25 februari 2008
Först inskickad som uppfyllde QC-kriterierna
25 februari 2008
Första postat (Uppskatta)
5 mars 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 december 2010
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 november 2010
Senast verifierad
1 november 2010
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D3540C00005
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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