Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00242775
Collaborator
(none)
2,100
143
12
14.7
1.2
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).
Study Start Date
:
May 1, 2005
Actual Study Completion Date
:
May 1, 2006
Outcome Measures
Primary Outcome Measures
- Time to first severe asthma exacerbation []
Secondary Outcome Measures
- Number of severe asthma exacerbations []
- Mild asthma exacerbations []
- FEV1 []
- Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries []
- Healthcare utilization []
- Safety (adverse events) []
- - all variables assessed over the 6 months treatment period []
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosed with asthma since at least 6 months prior to first visit
-
Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
-
At least one asthma exacerbation more than one but less than twelve months prior to first visit
Exclusion Criteria:
-
Respiratory infection affecting asthma within 30 days before first visit
-
Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
-
Any significant disease or disorder that may jeopardize the safety of the patient
Additional inclusion and exclusion criteria will be evaluated by the Investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Mar Del Plata | Buenos Aires | Argentina | |
| 2 | Research Site | Monte Grande | Buenos Aires | Argentina | |
| 3 | Research Site | San Miguel De Tucuman | Provincia De Tucuman | Argentina | |
| 4 | Research Site | Buenos Aires | Argentina | ||
| 5 | Research Site | Cordoba | Argentina | ||
| 6 | Research Site | Santa Fé | Argentina | ||
| 7 | Research Site | Tucuman | Argentina | ||
| 8 | Research Site | Bankstown | New South Wales | Australia | |
| 9 | Research Site | Sydney | New South Wales | Australia | |
| 10 | Research Site | Westmead | New South Wales | Australia | |
| 11 | Research Site | Bundaberg | Queensland | Australia | |
| 12 | Research Site | Carina Heights | Queensland | Australia | |
| 13 | Research Site | Mackay | Queensland | Australia | |
| 14 | Research Site | Ashford | South Australia | Australia | |
| 15 | Research Site | Toorak Gardens | South Australia | Australia | |
| 16 | Research Site | Woodville South | South Australia | Australia | |
| 17 | Research Site | Box Hill | Victoria | Australia | |
| 18 | Research Site | Malvern | Victoria | Australia | |
| 19 | Research Site | Prahran | Victoria | Australia | |
| 20 | Research Site | Rosebud | Victoria | Australia | |
| 21 | Research Site | Nedlands | Western Australia | Australia | |
| 22 | Research Site | Salvador | Bahia | Brazil | |
| 23 | Research Site | Juiz de Fora | MG | Brazil | |
| 24 | Research Site | Recife | Pernambuco | Brazil | |
| 25 | Research Site | Rio de Janeiro | RJ | Brazil | |
| 26 | Research Site | Florianópolis | Santa Catarina | Brazil | |
| 27 | Research Site | Sao Paulo | SP | Brazil | |
| 28 | Research Site | Curitiba | Brazil | ||
| 29 | Research Site | Sao Paulo | Brazil | ||
| 30 | Research Site | São Paulo | Brazil | ||
| 31 | Research Site | Edmonton | Alberta | Canada | |
| 32 | Research Site | Winnipeg | Manitoba | Canada | |
| 33 | Research Site | Mount Pearl | Newfoundland and Labrador | Canada | |
| 34 | Research Site | Hamilton | Ontario | Canada | |
| 35 | Research Site | London | Ontario | Canada | |
| 36 | Research Site | Mississauga | Ontario | Canada | |
| 37 | Research Site | North York | Ontario | Canada | |
| 38 | Research Site | Ottawa | Ontario | Canada | |
| 39 | Research Site | Toronto | Ontario | Canada | |
| 40 | Research Site | Montreal | Quebec | Canada | |
| 41 | Research Site | Saint-Leonard | Quebec | Canada | |
| 42 | Research Site | Ste-Foy | Quebec | Canada | |
| 43 | Research Site | Trois Rivieres | Quebec | Canada | |
| 44 | Research Site | Saskatoon | Saskatchewan | Canada | |
| 45 | Research Site | Quebec | Canada | ||
| 46 | Research Site | Beijing | China | ||
| 47 | Research Site | Guang Zhou | China | ||
| 48 | Research Site | Nan Jin | China | ||
| 49 | Research Site | Shanghai | China | ||
| 50 | Research Site | Shanxi | China | ||
| 51 | Research Site | Shenyang | China | ||
| 52 | Research Site | Angers | France | ||
| 53 | Research Site | Bernay | France | ||
| 54 | Research Site | Bethune | France | ||
| 55 | Research Site | Chamalieres | France | ||
| 56 | Research Site | Ferolles Attilly | France | ||
| 57 | Research Site | Grasse | France | ||
| 58 | Research Site | Henin Beaumont | France | ||
| 59 | Research Site | La Rochelle | France | ||
| 60 | Research Site | Laon | France | ||
| 61 | Research Site | Le Havre | France | ||
| 62 | Research Site | Lille | France | ||
| 63 | Research Site | Lorient | France | ||
| 64 | Research Site | MARSEILLE Cedex 06 | France | ||
| 65 | Research Site | Montereau Fault Yonne | France | ||
| 66 | Research Site | Montpellier | France | ||
| 67 | Research Site | Nantes | France | ||
| 68 | Research Site | NIMES Cedex 9 | France | ||
| 69 | Research Site | Paris | France | ||
| 70 | Research Site | Saint Denis | France | ||
| 71 | Research Site | Selestat | France | ||
| 72 | Research Site | St Laurent Du Var | France | ||
| 73 | Research Site | Toulouse Cedex 9 | France | ||
| 74 | Research Site | Villebon Sur Yvette | France | ||
| 75 | Research Site | Villejuif | France | ||
| 76 | Research Site | Cottbus | Brandenburg | Germany | |
| 77 | Research Site | Frankfurt | Hessen | Germany | |
| 78 | Research Site | Düsseldorf | Nordrhein-Westfalen | Germany | |
| 79 | Research Site | Münster | Nordrhein-Westfalen | Germany | |
| 80 | Research Site | Bad Segeberg | Schleswig-Holstein | Germany | |
| 81 | Research Site | Jena-Maua | Thüringen | Germany | |
| 82 | Research Site | Berlin | Germany | ||
| 83 | Research Site | Bonn | Germany | ||
| 84 | Research Site | Düsseldorf | Germany | ||
| 85 | Research Site | Erfurt | Germany | ||
| 86 | Research Site | Geesthacht | Germany | ||
| 87 | Research Site | Großhansdorf | Germany | ||
| 88 | Research Site | Hagen | Germany | ||
| 89 | Research Site | Hamburg | Germany | ||
| 90 | Research Site | Kassel | Germany | ||
| 91 | Research Site | Koblenz | Germany | ||
| 92 | Research Site | Lübeck | Germany | ||
| 93 | Research Site | Marburg | Germany | ||
| 94 | Research Site | Neuruppin | Germany | ||
| 95 | Research Site | Sonneberg | Germany | ||
| 96 | Research Site | Witten | Germany | ||
| 97 | Research Site | Coimbatore | India | ||
| 98 | Research Site | Hyderbad | India | ||
| 99 | Research Site | Mumbai | India | ||
| 100 | Research Site | Noida | India | ||
| 101 | Research Site | Jakarta Timur | Jakarta - Indonesia | Indonesia | |
| 102 | Research Site | Semarang | Jawa Tengah | Indonesia | |
| 103 | Research Site | Bandung | Indonesia | ||
| 104 | Research Site | Jakarta Timur | Indonesia | ||
| 105 | Research Site | Jakarta | Indonesia | ||
| 106 | Research Site | Solo | Indonesia | ||
| 107 | Research Site | Kuala Lumpur | Malaysia | ||
| 108 | Research Site | Seremban | Malaysia | ||
| 109 | Research Site | Zapopan | Jalisco | Mexico | |
| 110 | Research Site | Villahermosa | Tabasco | Mexico | |
| 111 | Research Site | Mexico | Mexico | ||
| 112 | Research Site | Cebu City | Philippines | ||
| 113 | Research Site | Iloilo City | Philippines | ||
| 114 | Research Site | Quezon City | Philippines | ||
| 115 | Research Site | Singapore | Singapore | ||
| 116 | Research Site | Bryanston | Gauteng | South Africa | |
| 117 | Research Site | Florida Park | Gauteng | South Africa | |
| 118 | Research Site | Lenasia | Gauteng | South Africa | |
| 119 | Research Site | Linksfield | Gauteng | South Africa | |
| 120 | Research Site | Sandton | Gauteng | South Africa | |
| 121 | Research Site | Witbank | Gauteng | South Africa | |
| 122 | Research Site | Hillcrest | Pretoria | South Africa | |
| 123 | Research Site | Bellville | South Africa | ||
| 124 | Research Site | Bloemfontein | South Africa | ||
| 125 | Research Site | Cape Town | South Africa | ||
| 126 | Research Site | Durban | South Africa | ||
| 127 | Research Site | Johannesburg | South Africa | ||
| 128 | Research Site | Lyttelton Manor | South Africa | ||
| 129 | Research Site | Pretoria | South Africa | ||
| 130 | Research Site | Umkomaas | South Africa | ||
| 131 | Research Site | San Sebastián | Guipuzcoa | Spain | |
| 132 | Research Site | El Palmar | Murcia | Spain | |
| 133 | Research Site | Barcelona | Spain | ||
| 134 | Research Site | Granada | Spain | ||
| 135 | Research Site | Jaén | Spain | ||
| 136 | Research Site | Madrid | Spain | ||
| 137 | Research Site | Santander | Spain | ||
| 138 | Research Site | Sevilla | Spain | ||
| 139 | Research Site | Vitoria | Spain | ||
| 140 | Research Site | Zaragoza | Spain | ||
| 141 | Research Site | Bangkok | Thailand | ||
| 142 | Research Site | Khon Kaen | Thailand | ||
| 143 | Research Site | Ho Chi Minh | Vietnam |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: AstraZeneca Symbicort Medical Science Director, MD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00242775
Other Study ID Numbers:
- D5890C00002
- EurodraCT No. 2004-004905-11
- AHEAD
First Posted:
Oct 21, 2005
Last Update Posted:
Jan 24, 2011
Last Verified:
Jan 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms: