SHARE - Symbicort and Health Economics in a Real Life Evaluation

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00259766
Collaborator
(none)
1,970
108
37
18.2
0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Symbicort and Health Economics in a Real Life Evaluation - SHARE - A Randomised, Open-Label, Parallel-Group, Multicentre Study to Assess the Asthma-Related Health-Care Costs, in Ordinary Clinical Practice During 12 Months
Study Start Date :
Apr 1, 2004
Actual Study Completion Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities []

Secondary Outcome Measures

  1. Number of days patients or assistant persons are absent from work due to patient's asthma []

  2. Number of exacerbations and treatment failures []

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Signed informed consent,

  • asthma,

  • previously treated with glucocorticosteroids and B2-agonist

Exclusion Criteria:
  • History of smoking, pregnancy, any significant disease or disorder which may put the patient at risk because of study participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Akersberga Sweden
2 Research Site Alingsas Sweden
3 Research Site Angelholm Sweden
4 Research Site Angered Sweden
5 Research Site Arlov Sweden
6 Research Site Arvidsjaur Sweden
7 Research Site Arvika Sweden
8 Research Site Atvidaberg Sweden
9 Research Site Bandhagen Sweden
10 Research Site Boden Sweden
11 Research Site Borensberg Sweden
12 Research Site Bro Sweden
13 Research Site Brunflo Sweden
14 Research Site Eskilstuna Sweden
15 Research Site Falun Sweden
16 Research Site Filipstad Sweden
17 Research Site Fränsta Sweden
18 Research Site Gagnef Sweden
19 Research Site Grängesberg Sweden
20 Research Site Gullspång Sweden
21 Research Site Gärsnäs Sweden
22 Research Site Göteborg Sweden
23 Research Site Haby Sweden
24 Research Site Halmstad Sweden
25 Research Site Helsingborg Sweden
26 Research Site Hisingsbacka Sweden
27 Research Site Hofors Sweden
28 Research Site Hollviken Sweden
29 Research Site Huddinge Sweden
30 Research Site Höganäs Sweden
31 Research Site Iggesund Sweden
32 Research Site Jarfalla Sweden
33 Research Site Kalmar Sweden
34 Research site Karlskoga Sweden
35 Research Site Karlstad Sweden
36 Research Site Katrineholm Sweden
37 Research Site Kil Sweden
38 Research Site Kinna Sweden
39 Research Site Klippan Sweden
40 Research Site Kolmården Sweden
41 Research Site Kristinehamn Sweden
42 Research Site Kungalv Sweden
43 Research Site Kungsbacka Sweden
44 Research Site Kungsör Sweden
45 Research Site Landskrona Sweden
46 Research Site Laxå Sweden
47 Research Site Leksand Sweden
48 Research Site Lerum Sweden
49 Research Site Lidingö Sweden
50 Research Site Likenäs Sweden
51 Research Site Limhamn Sweden
52 Research Site Lindome Sweden
53 Research Site Linköping Sweden
54 Research Site Ljungskile Sweden
55 Research Site Ludvika Sweden
56 Research Site Luleå Sweden
57 Research Site Lund Sweden
58 Research Site Malmo Sweden
59 Research Site Mariefred Sweden
60 Research Site Molndal Sweden
61 Research site Molnlycke Sweden
62 Research Site Nacka Sweden
63 Research Site Norrkoping Sweden
64 Research Site Norrtälje Sweden
65 Research Site Nyköping Sweden
66 Research site Osby Sweden
67 Research Site Partille Sweden
68 Reseearch Site Perstorp Sweden
69 Research Site Påarp Sweden
70 Research Site Saltsjo-Bo Sweden
71 Research Site Sandviken Sweden
72 Research Site Sjobo Sweden
73 Research Site Sjuntorp Sweden
74 Research site Sollentuna Sweden
75 Research Site Solna Sweden
76 Research site Stenstorp Sweden
77 Research Site Stenungsund Sweden
78 Research Site Stockholm Sweden
79 Research Site Storfors Sweden
80 Research Site Stugun Sweden
81 Research Site Sundbyberg Sweden
82 Research Site Sundsvall Sweden
83 Research Site Sunne Sweden
84 Research Site Söderköping Sweden
85 Research Site Trollhättan Sweden
86 Research Site Trosa Sweden
87 Research Site Tyresö Sweden
88 Research Site Täby Sweden
89 Research Site Uddevalla Sweden
90 Research site Ulricehamn Sweden
91 Research Site Umeå Sweden
92 Research Site Uppsala Sweden
93 Research Site Vallentuna Sweden
94 Research Site Varberg Sweden
95 Research Site Varnamo Sweden
96 Research Site Vellinge Sweden
97 Research Site Vännäs Sweden
98 Research site Väsby Sweden
99 Research Site Västervik Sweden
100 Research Site Västerås Sweden
101 Research site Västra Frölunda Sweden
102 Research Site Ystad Sweden
103 Research Site Ytterby Sweden
104 Research Site Ånge Sweden
105 Research Site Årsta Sweden
106 Research Site Åstorp Sweden
107 Research site Ödeshög Sweden
108 Research Site Örebro Sweden

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:
NCT00259766
Other Study ID Numbers:
  • D5890L00001
  • SHARE
First Posted:
Dec 1, 2005
Last Update Posted:
Jan 24, 2011
Last Verified:
Jan 1, 2011
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2011