Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients (Sweapea)
11. oktober 2013 oppdatert av: AstraZeneca
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
The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1144
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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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, Brasil
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ES
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Vitoria, ES, Brasil
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MG
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Belo Horizonte, MG, Brasil
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Juiz de Fora, MG, Brasil
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RS
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Porto Alegre, RS, Brasil
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SP
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Santo Andre, SP, Brasil
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Sao Paulo, SP, Brasil
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Santa Catarina
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Florian Polis, Santa Catarina, Brasil
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Novosibirsk, Den russiske føderasjonen
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Saint Petersburg, Den russiske føderasjonen
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St. Petersburg, Den russiske føderasjonen
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Vladikavkaz, Den russiske føderasjonen
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Russia
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Ekaterinburg, Russia, Den russiske føderasjonen
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Moscow, Russia, Den russiske føderasjonen
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California
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Fullerton, California, Forente stater
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Los Angeles, California, Forente stater
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Mission Viejo, California, Forente stater
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Rolling Hills Estates, California, Forente stater
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San Diego, California, Forente stater
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San Jose, California, Forente stater
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Maryland
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Wheaton, Maryland, Forente stater
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Massachusetts
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North Dartmouth, Massachusetts, Forente stater
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Nebraska
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Bellevue, Nebraska, Forente stater
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Ohio
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Sylvania, Ohio, Forente stater
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater
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Oregon
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Medford, Oregon, Forente stater
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Portland, Oregon, Forente stater
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Pennsylvania
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Collegeville, Pennsylvania, Forente stater
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Pittsburgh, Pennsylvania, Forente stater
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South Carolina
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Charleston, South Carolina, Forente stater
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Clinton, South Carolina, Forente stater
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Texas
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Waco, Texas, Forente stater
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Washington
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Tacoma, Washington, Forente 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, Romania
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Bucharest, Romania
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Bucuresti, Romania
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Cluj Napoca, Romania
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Constanta, Romania
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Iasi, Romania
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Tg. Mures, Romania
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Banska Bystrica, Slovakia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Dunajska Streda, Slovakia
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Hnusta, Slovakia
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Komarno, Slovakia
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Kosice, Slovakia
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Levice, Slovakia
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Liptovsky Hradok, Slovakia
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Liptovsky Mikulas, Slovakia
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Presov, Slovakia
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Rimavska Sobota, Slovakia
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Ruzomberok, Slovakia
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Trencin, Slovakia
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Zvolen, Slovakia
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Amanzimtoti, Sør-Afrika
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Cape Town, Sør-Afrika
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Durban, Sør-Afrika
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Durbanville, Sør-Afrika
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Pretoria, Sør-Afrika
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Umkomaas, Sør-Afrika
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Centurion
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Lyttleton, Centurion, Sør-Afrika
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Kwazulu Natal
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Durban, Kwazulu Natal, Sør-Afrika
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Dnipropetrovsk, Ukraina
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Donetsk, Ukraina
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Kharkiv, Ukraina
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Kyiv, Ukraina
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Odesa, Ukraina
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Poltava, Ukraina
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Vinytsa, Ukraina
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Zaporozhye, Ukraina
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
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
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 to match AZD1981
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Eksperimentell: AZD1981 10 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentell: AZD1981 40 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentell: AZD1981 100 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentell: AZD1981 400 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentell: AZD1981 80 mg
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AZD1981 twice daily
AZD1981 once daily
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Eksperimentell: AZD1981 200 mg
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AZD1981 twice daily
AZD1981 once daily
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Morning and Evening PEF
Tidsramme: Twelve week treatment period
|
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.
|
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
|
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.
|
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.
|
Twelve week treatment period
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Asthma Symptom Score
Tidsramme: Twelve week treatment period
|
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.
|
Twelve week treatment period
|
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Total Reliever Medication Use
Tidsramme: Twelve week treatment period
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Chris O'Brien, MD, AstraZeneca
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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. oktober 2010
Primær fullføring (Faktiske)
1. februar 2012
Studiet fullført (Faktiske)
1. februar 2012
Datoer for studieregistrering
Først innsendt
8. september 2010
Først innsendt som oppfylte QC-kriteriene
8. september 2010
Først lagt ut (Anslag)
9. september 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. november 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. oktober 2013
Sist bekreftet
1. oktober 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D9830C00008
- 2010-020407-73 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .