Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients (Sweapea)
11 oktober 2013 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
1144
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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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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California
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Fullerton, California, Förenta staterna
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Los Angeles, California, Förenta staterna
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Mission Viejo, California, Förenta staterna
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Rolling Hills Estates, California, Förenta staterna
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San Diego, California, Förenta staterna
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San Jose, California, Förenta staterna
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Maryland
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Wheaton, Maryland, Förenta staterna
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Massachusetts
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North Dartmouth, Massachusetts, Förenta staterna
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Nebraska
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Bellevue, Nebraska, Förenta staterna
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Ohio
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Sylvania, Ohio, Förenta staterna
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna
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Oregon
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Medford, Oregon, Förenta staterna
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Portland, Oregon, Förenta staterna
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Pennsylvania
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Collegeville, Pennsylvania, Förenta staterna
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Pittsburgh, Pennsylvania, Förenta staterna
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South Carolina
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Charleston, South Carolina, Förenta staterna
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Clinton, South Carolina, Förenta staterna
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Texas
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Waco, Texas, Förenta staterna
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Washington
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Tacoma, Washington, Förenta staterna
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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, Mexiko
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Baja California
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Tijuana, Baja California, Mexiko
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D.f.
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Mexico, D.f., Mexiko
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Michoacan
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Morelia, Michoacan, Mexiko
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexiko
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Brasov, Rumänien
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Bucharest, Rumänien
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Bucuresti, Rumänien
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Cluj Napoca, Rumänien
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Constanta, Rumänien
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Iasi, Rumänien
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Tg. Mures, Rumänien
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Novosibirsk, Ryska Federationen
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Saint Petersburg, Ryska Federationen
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St. Petersburg, Ryska Federationen
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Vladikavkaz, Ryska Federationen
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Russia
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Ekaterinburg, Russia, Ryska Federationen
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Moscow, Russia, Ryska Federationen
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Banska Bystrica, Slovakien
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Bardejov, Slovakien
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Bratislava, Slovakien
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Dunajska Streda, Slovakien
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Hnusta, Slovakien
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Komarno, Slovakien
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Kosice, Slovakien
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Levice, Slovakien
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Liptovsky Hradok, Slovakien
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Liptovsky Mikulas, Slovakien
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Presov, Slovakien
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Rimavska Sobota, Slovakien
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Ruzomberok, Slovakien
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Trencin, Slovakien
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Zvolen, Slovakien
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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, 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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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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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: Placebo
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Placebo to match AZD1981
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Experimentell: AZD1981 10 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimentell: AZD1981 40 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimentell: AZD1981 100 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimentell: AZD1981 400 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimentell: AZD1981 80 mg
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AZD1981 twice daily
AZD1981 once daily
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Experimentell: AZD1981 200 mg
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AZD1981 twice daily
AZD1981 once daily
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pre-bronchodilator FEV1 at the Clinic
Tidsram: Twelve week treatment period
|
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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Morning and Evening PEF
Tidsram: 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)
Tidsram: 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.
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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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))
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Twelve week treatment period
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Chris O'Brien, MD, AstraZeneca
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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 oktober 2010
Primärt slutförande (Faktisk)
1 februari 2012
Avslutad studie (Faktisk)
1 februari 2012
Studieregistreringsdatum
Först inskickad
8 september 2010
Först inskickad som uppfyllde QC-kriterierna
8 september 2010
Första postat (Uppskatta)
9 september 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 november 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 oktober 2013
Senast verifierad
1 oktober 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D9830C00008
- 2010-020407-73 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .