Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients (Sweapea)
A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Buenos Aires, Argentinien
- Research Site
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Mendoza, Argentinien
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Buenos Aires
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Quilmes, Buenos Aires, Argentinien
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Santa Fe
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Rosario, Santa Fe, Argentinien
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Tucuman
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San Miguel de Tucuman, Tucuman, Argentinien
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Brasil
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Porto Alegre, Brasil, Brasilien
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ES
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Vitoria, ES, Brasilien
- Research Site
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MG
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Belo Horizonte, MG, Brasilien
- Research Site
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Juiz de Fora, MG, Brasilien
- Research Site
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RS
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Porto Alegre, RS, Brasilien
- Research Site
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SP
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Santo Andre, SP, Brasilien
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Sao Paulo, SP, Brasilien
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Santa Catarina
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Florian Polis, Santa Catarina, Brasilien
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Kochi, Japan
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Kyoto, Japan
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Oita, Japan
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Fukuoka
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Yanagawa, Fukuoka, Japan
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan
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Hokkaido
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Asahikawa, Hokkaido, Japan
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Chitose, Hokkaido, Japan
- Research Site
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Kitahiroshima, Hokkaido, Japan
- Research Site
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Obihiro, Hokkaido, Japan
- Research Site
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Sapporo, Hokkaido, Japan
- Research Site
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Tomakomai, Hokkaido, Japan
- Research Site
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Hyogo
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Himeji, Hyogo, Japan
- Research Site
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Ibaraki
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Naka-gun, Ibaraki, Japan
- Research Site
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Kagawa
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Sakaide, Kagawa, Japan
- Research Site
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Kanagawa
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Fujisawa-shi, Kanagawa, Japan
- Research Site
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Yokohama, Kanagawa, Japan
- Research Site
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Niigata
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Nagaoka, Niigata, Japan
- Research Site
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Oita
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Beppu, Oita, Japan
- Research Site
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Okayama
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Kurashiki-shi, Okayama, Japan
- Research Site
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Shimane
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Matsue, Shimane, Japan
- Research Site
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Tokyo
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Chuo, Tokyo, Japan
- Research Site
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Chuo-ku, Tokyo, Japan
- Research Site
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Itabashi-ku, Tokyo, Japan
- Research Site
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Kodaira, Tokyo, Japan
- Research Site
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Nakano-ku, Tokyo, Japan
- Research Site
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Ohota-ku, Tokyo, Japan
- Research Site
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Guadalajara, Mexiko
- Research Site
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Baja California
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Tijuana, Baja California, Mexiko
- Research Site
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D.f.
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Mexico, D.f., Mexiko
- Research Site
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Michoacan
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Morelia, Michoacan, Mexiko
- Research Site
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexiko
- Research Site
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Brasov, Rumänien
- Research Site
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Bucharest, Rumänien
- Research Site
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Bucuresti, Rumänien
- Research Site
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Cluj Napoca, Rumänien
- Research Site
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Constanta, Rumänien
- Research Site
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Iasi, Rumänien
- Research Site
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Tg. Mures, Rumänien
- Research Site
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Novosibirsk, Russische Föderation
- Research Site
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Saint Petersburg, Russische Föderation
- Research Site
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St. Petersburg, Russische Föderation
- Research Site
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Vladikavkaz, Russische Föderation
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Russia
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Ekaterinburg, Russia, Russische Föderation
- Research Site
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Moscow, Russia, Russische Föderation
- Research Site
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Banska Bystrica, Slowakei
- Research Site
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Bardejov, Slowakei
- Research Site
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Bratislava, Slowakei
- Research Site
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Dunajska Streda, Slowakei
- Research Site
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Hnusta, Slowakei
- Research Site
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Komarno, Slowakei
- Research Site
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Kosice, Slowakei
- Research Site
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Levice, Slowakei
- Research Site
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Liptovsky Hradok, Slowakei
- Research Site
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Liptovsky Mikulas, Slowakei
- Research Site
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Presov, Slowakei
- Research Site
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Rimavska Sobota, Slowakei
- Research Site
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Ruzomberok, Slowakei
- Research Site
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Trencin, Slowakei
- Research Site
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Zvolen, Slowakei
- Research Site
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Amanzimtoti, Südafrika
- Research Site
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Cape Town, Südafrika
- Research Site
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Durban, Südafrika
- Research Site
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Durbanville, Südafrika
- Research Site
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Pretoria, Südafrika
- Research Site
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Umkomaas, Südafrika
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Centurion
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Lyttleton, Centurion, Südafrika
- Research Site
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Kwazulu Natal
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Durban, Kwazulu Natal, Südafrika
- Research Site
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Dnipropetrovsk, Ukraine
- Research Site
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Donetsk, Ukraine
- Research Site
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Kharkiv, Ukraine
- Research Site
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Kyiv, Ukraine
- Research Site
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Odesa, Ukraine
- Research Site
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Poltava, Ukraine
- Research Site
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Vinytsa, Ukraine
- Research Site
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Zaporozhye, Ukraine
- Research Site
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California
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Fullerton, California, Vereinigte Staaten
- Research Site
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Los Angeles, California, Vereinigte Staaten
- Research Site
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Mission Viejo, California, Vereinigte Staaten
- Research Site
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Rolling Hills Estates, California, Vereinigte Staaten
- Research Site
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San Diego, California, Vereinigte Staaten
- Research Site
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San Jose, California, Vereinigte Staaten
- Research Site
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Maryland
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Wheaton, Maryland, Vereinigte Staaten
- Research Site
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Massachusetts
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North Dartmouth, Massachusetts, Vereinigte Staaten
- Research Site
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Nebraska
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Bellevue, Nebraska, Vereinigte Staaten
- Research Site
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Ohio
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Sylvania, Ohio, Vereinigte Staaten
- Research Site
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten
- Research Site
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Oregon
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Medford, Oregon, Vereinigte Staaten
- Research Site
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Portland, Oregon, Vereinigte Staaten
- Research Site
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Pennsylvania
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Collegeville, Pennsylvania, Vereinigte Staaten
- Research Site
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Pittsburgh, Pennsylvania, Vereinigte Staaten
- Research Site
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten
- Research Site
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Clinton, South Carolina, Vereinigte Staaten
- Research Site
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Texas
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Waco, Texas, Vereinigte Staaten
- Research Site
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Washington
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Tacoma, Washington, Vereinigte Staaten
- Research Site
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
- 6 months history of asthma according to ATS definition
- Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
- Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
- A total ACQ5 score of 1.5 or more
Exclusion Criteria:
- Respiratory infection significantly affecting the asthma
- Any significant disease and disorder that may put the patient at risk or influence study results
- Any clinically relevant abnormal findings
- A smoking history of more than 10 pack years
- Intake of oral, rectal or parenteral glucocorticosteroids
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Placebo-Komparator: Placebo
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Placebo to match AZD1981
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Experimental: AZD1981 10 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimental: AZD1981 40 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimental: AZD1981 100 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimental: AZD1981 400 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimental: AZD1981 80 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimental: AZD1981 200 mg
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AZD1981 twice daily
AZD1981 once daily
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pre-bronchodilator FEV1 at the Clinic
Zeitfenster: Twelve week treatment period
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Change from baseline: treatment period average minus baseline.
Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure.
Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
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Twelve week treatment period
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Morning and Evening PEF
Zeitfenster: Twelve week treatment period
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Change from baseline: treatment period average minus baseline.
Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure.
Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
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Twelve week treatment period
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Asthma Control Questionnaire 5-item (ACQ5)
Zeitfenster: Twelve week treatment period
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The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control.
The overall score is the mean of the responses.
The minimal important difference is defined as a change in score of 0.5.
Change from baseline: treatment period average minus baseline.
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Twelve week treatment period
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Adverse Events
Zeitfenster: Twelve week treatment period
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Number of participants who had at least one adverse event during the randomized treatment period
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Twelve week treatment period
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Number of Participants With at Least One Severe Asthma Exacerbation
Zeitfenster: Twelve week treatment period
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Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days
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Twelve week treatment period
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Number of Participants With at Least One Treatment Failure
Zeitfenster: Twelve week treatment period
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Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.
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Twelve week treatment period
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Number of Participants With Well-controlled Asthma (ACQ5<=0.75)
Zeitfenster: Twelve week treatment period
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The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control.
The overall score is the mean of the responses.
Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.
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Twelve week treatment period
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Asthma Quality of Life Questionnaire (AQLQ(S))
Zeitfenster: Twelve week treatment period
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The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life.
Overall scores are calculated from the means of the individual scores.
The minimal important difference is a change in score of 0.5.
Change from baseline: treatment period average minus baseline.
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Twelve week treatment period
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Asthma Symptom Score
Zeitfenster: Twelve week treatment period
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Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms.
Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores.
Change from baseline: treatment period average minus baseline.
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Twelve week treatment period
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Total Reliever Medication Use
Zeitfenster: Twelve week treatment period
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Reliever medication use (number of inhalations), measured in the morning and evening.
Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication.
Change from baseline: treatment period average minus baseline.
|
Twelve week treatment period
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Studienleiter: Chris O'Brien, MD, AstraZeneca
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- D9830C00008
- 2010-020407-73 (EudraCT-Nummer)
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