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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Buenos Aires, Argentina
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Mendoza, Argentina
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Buenos Aires
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Quilmes, Buenos Aires, Argentina
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Santa Fe
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Rosario, Santa Fe, Argentina
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Tucuman
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San Miguel de Tucuman, Tucuman, Argentina
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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
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MG
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Belo Horizonte, MG, Brasilien
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Juiz de Fora, MG, Brasilien
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RS
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Porto Alegre, RS, Brasilien
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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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Novosibirsk, Den Russiske Føderation
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Saint Petersburg, Den Russiske Føderation
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St. Petersburg, Den Russiske Føderation
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Vladikavkaz, Den Russiske Føderation
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Russia
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Ekaterinburg, Russia, Den Russiske Føderation
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Moscow, Russia, Den Russiske Føderation
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California
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Fullerton, California, Forenede Stater
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Los Angeles, California, Forenede Stater
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Mission Viejo, California, Forenede Stater
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Rolling Hills Estates, California, Forenede Stater
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San Diego, California, Forenede Stater
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San Jose, California, Forenede Stater
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Maryland
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Wheaton, Maryland, Forenede Stater
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Massachusetts
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North Dartmouth, Massachusetts, Forenede Stater
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Nebraska
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Bellevue, Nebraska, Forenede Stater
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Ohio
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Sylvania, Ohio, Forenede Stater
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater
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Oregon
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Medford, Oregon, Forenede Stater
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Portland, Oregon, Forenede Stater
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Pennsylvania
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Collegeville, Pennsylvania, Forenede Stater
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Pittsburgh, Pennsylvania, Forenede Stater
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South Carolina
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Charleston, South Carolina, Forenede Stater
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Clinton, South Carolina, Forenede Stater
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Texas
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Waco, Texas, Forenede Stater
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Washington
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Tacoma, Washington, Forenede Stater
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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
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Kitahiroshima, Hokkaido, Japan
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Obihiro, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Hyogo
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Himeji, Hyogo, Japan
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Ibaraki
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Naka-gun, Ibaraki, Japan
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Kagawa
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Sakaide, Kagawa, Japan
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Kanagawa
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Fujisawa-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Niigata
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Nagaoka, Niigata, Japan
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Oita
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Beppu, Oita, Japan
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Okayama
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Kurashiki-shi, Okayama, Japan
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Shimane
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Matsue, Shimane, Japan
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Tokyo
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Chuo, Tokyo, Japan
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Chuo-ku, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Nakano-ku, Tokyo, Japan
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Ohota-ku, Tokyo, Japan
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Guadalajara, Mexico
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Baja California
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Tijuana, Baja California, Mexico
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D.f.
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Mexico, D.f., Mexico
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Michoacan
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Morelia, Michoacan, Mexico
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico
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Brasov, Rumænien
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Bucharest, Rumænien
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Bucuresti, Rumænien
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Cluj Napoca, Rumænien
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Constanta, Rumænien
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Iasi, Rumænien
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Tg. Mures, Rumænien
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Banska Bystrica, Slovakiet
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Bardejov, Slovakiet
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Bratislava, Slovakiet
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Dunajska Streda, Slovakiet
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Hnusta, Slovakiet
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Komarno, Slovakiet
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Kosice, Slovakiet
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Levice, Slovakiet
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Liptovsky Hradok, Slovakiet
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Liptovsky Mikulas, Slovakiet
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Presov, Slovakiet
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Rimavska Sobota, Slovakiet
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Ruzomberok, Slovakiet
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Trencin, Slovakiet
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Zvolen, Slovakiet
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Amanzimtoti, Sydafrika
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Cape Town, Sydafrika
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Durban, Sydafrika
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Durbanville, Sydafrika
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Pretoria, Sydafrika
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Umkomaas, Sydafrika
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Centurion
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Lyttleton, Centurion, Sydafrika
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Kwazulu Natal
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Durban, Kwazulu Natal, Sydafrika
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Vinytsa, Ukraine
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Zaporozhye, Ukraine
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Placebo komparator: Placebo
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Placebo to match AZD1981
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Eksperimentel: AZD1981 10 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentel: AZD1981 40 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentel: AZD1981 100 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentel: AZD1981 400 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentel: AZD1981 80 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentel: AZD1981 200 mg
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AZD1981 twice daily
AZD1981 once daily
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pre-bronchodilator FEV1 at the Clinic
Tidsramme: 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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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Morning and Evening PEF
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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))
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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Twelve week treatment period
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Chris O'Brien, MD, AstraZeneca
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- D9830C00008
- 2010-020407-73 (EudraCT nummer)
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