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CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE® Inhaler With An Adjustable Maintenance Dose Of SYMBICORT® Inhaler. SERETIDE® Inhaler is a Trademark of GSK Group of Companies. SYMBICORT® Inhaler is a Trademark of Astra Zeneca.

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00479739
Collaborator
(none)
700
Enrollment
106
Locations
1
Arm
20
Duration (Months)
6.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of formoterol/budesonide where the dose is adjusted according to a physician-guided self-management plan

Condition or Disease Intervention/Treatment Phase
  • Drug: Salmeterol/fluticasone propionate or formoterol/budesonide
 Phase 4

Detailed Description

A randomised, double-blind, double-dummy, 52-week, parallel group study of a standard dosing regimen with salmeterol/fluticasone propionate combination 50/250mcg bid (via the DISKUS/ACCUHALER inhaler) versus a symptom-driven variable dosing regimen with formoterol/budesonide combination 6/200mcg (via a breath-actuated dry powder reservoir inhaler)in adults asthmatics

Study Design

Study Type:
Interventional
Actual Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomised, Double-blind, Double-dummy, 52-week, Parallel Group Study of a Standard Dosing Regimen With Salmeterol/Fluticasone propionate50/250 Twice Daily Diskus Versus a Symptom-driven, Variable Dosing Regimen With Formoterol/Budesonide Combination 4.5/160 in Adult Asthmatics
Study Start Date :
Nov 1, 2002
Actual Primary Completion Date :
Jul 1, 2004
Actual Study Completion Date :
Jul 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Drug: Salmeterol/fluticasone propionate or formoterol/budesonide

Outcome Measures

Primary Outcome Measures

  1. Mean percentage of symptom-free days over a 52-week treatment period []

Secondary Outcome Measures

  1. Mean percentage of rescue-free days Daily asthma symptom scores Daily rescue usage Mean morning peak flow Percentage of nights awoken due to asthma Rate of exacerbations Airway hyper-responsiveness(PC20 AMP) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Documented clinical history of asthma

  • Forced expiratory volume in 1 second between 60% and 90% of predicted

  • Using an inhaled corticosteroid (ICS)at a dose equivalent to 200 to 500 mcg daily of beclomethasone (BDP)or equivalent combined with a long-acting beta-2-agonist or an ICS alone at a dose equivalent to >500 to 1000mcg daily of BDP daily

Exclusion Criteria:

  • Lower respiratory tract infection within 1 month of study entry

  • Use of systemic corticosteroids within 1 month of study entry

  • Smoking history of 10 pack years or more Changes in regular asthma therapy within 12 weeks of study entry

  • Any significant disorder that in the investigator's opinion might put the patient at risk or influence the study outcomes

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Balmain New South Wales Australia 2041
2 GSK Investigational Site Brisbane Queensland Australia 4077
3 GSK Investigational Site Kippa Ring Queensland Australia 4021
4 GSK Investigational Site Toorak Gardens South Australia Australia 5065
5 GSK Investigational Site Linz Austria A-4020
6 GSK Investigational Site Vienna Austria A-1030
7 GSK Investigational Site Vienna Austria A-1120
8 GSK Investigational Site Vienna Austria A-1210
9 GSK Investigational Site Aalst Belgium 9300
10 GSK Investigational Site Ath Belgium 7800
11 GSK Investigational Site Gilly Belgium 6060
12 GSK Investigational Site Hornu Belgium 7301
13 GSK Investigational Site Leopoldsburg Belgium 3970
14 GSK Investigational Site Oostham Belgium 3945
15 GSK Investigational Site Tessenderlo Belgium 3980
16 GSK Investigational Site Tienen Belgium 3300
17 GSK Investigational Site Plovdiv Bulgaria
18 GSK Investigational Site Rousse Bulgaria 7000
19 GSK Investigational Site Sofia Bulgaria 1606
20 GSK Investigational Site Varna Bulgaria 9010
21 GSK Investigational Site Calgary Alberta Canada T2N 4N1
22 GSK Investigational Site Maple Ridge British Columbia Canada V2X 2L5
23 GSK Investigational Site Vancouver British Columbia Canada V5Z 3J5
24 GSK Investigational Site Winnipeg Manitoba Canada R2H 2A6
25 GSK Investigational Site Saint John New Brunswick Canada E2M 3W5
26 GSK Investigational Site Brampton Ontario Canada L6Y 2E6
27 GSK Investigational Site Hamilton Ontario Canada L8N 3Z5
28 GSK Investigational Site Mississauga Ontario Canada L5A 1N1
29 GSK Investigational Site Mississauga Ontario Canada L5M 2V8
30 GSK Investigational Site Peterborough Ontario Canada K9J 7B3
31 GSK Investigational Site Montreal Quebec Canada H3G 1A4
32 GSK Investigational Site Montreal Quebec Canada H4J 1C5
33 GSK Investigational Site Sainte-Foy Quebec Canada G1V 4G5
34 GSK Investigational Site Kohtal-Jdrve Estonia 31 025
35 GSK Investigational Site Tallinn Estonia 10120
36 GSK Investigational Site Tallinn Estonia 13419
37 GSK Investigational Site Tartu Estonia 51014
38 GSK Investigational Site Joensuu Finland 80100
39 GSK Investigational Site Lahti Finland 15850
40 GSK Investigational Site Pietarsaari Finland 68600
41 GSK Investigational Site Raahe Finland 92100
42 GSK Investigational Site Tampere Finland 33520
43 GSK Investigational Site Varkaus Finland 78300
44 GSK Investigational Site Bruchsal Baden-Wuerttemberg Germany 76646
45 GSK Investigational Site Lahr Baden-Wuerttemberg Germany 77933
46 GSK Investigational Site Augsburg Bayern Germany 86150
47 GSK Investigational Site Erlangen Bayern Germany 91052
48 GSK Investigational Site Muenchen Bayern Germany 81677
49 GSK Investigational Site Potsdam Brandenburg Germany 14469
50 GSK Investigational Site Berlin Germany 10178
51 GSK Investigational Site Berlin Germany 10717
52 GSK Investigational Site Berlin Germany 13086
53 GSK Investigational Site Berlin Germany 13187
54 GSK Investigational Site Berlin Germany 13353
55 GSK Investigational Site Berlin Germany 13597
56 GSK Investigational Site Blackpool, Cork Ireland
57 GSK Investigational Site Dublin Ireland 22
58 GSK Investigational Site Dublin Ireland 6
59 GSK Investigational Site Dublin Ireland 8
60 GSK Investigational Site Dublin Ireland
61 GSK Investigational Site Galway Ireland
62 GSK Investigational Site Kilkenny Ireland
63 GSK Investigational Site Lifford Ireland
64 GSK Investigational Site Tallaght, Dublin Ireland 24
65 GSK Investigational Site Limbazi Latvia LV 4000
66 GSK Investigational Site Riga Latvia LV 1002
67 GSK Investigational Site Riga Latvia LV 1035
68 GSK Investigational Site Valmiera Latvia LV 4201
69 GSK Investigational Site Skopje Macedonia, The Former Yugoslav Republic of 9100
70 GSK Investigational Site 's-HERTOGENBOSCH Netherlands 5211 NL
71 GSK Investigational Site Almelo Netherlands 7609 PP
72 GSK Investigational Site Bennebroek Netherlands 2121 BB
73 GSK Investigational Site Eindhoven Netherlands 5623 EJ
74 GSK Investigational Site Geldermalsen Netherlands 4191 AH
75 GSK Investigational Site Heerlen Netherlands 6419 PC
76 GSK Investigational Site Helmond Netherlands 5707 HA
77 GSK Investigational Site Losser Netherlands 7581 BV
78 GSK Investigational Site Made Netherlands 4921 BC
79 GSK Investigational Site Rotterdam Netherlands 3015 GD
80 GSK Investigational Site Spijkenisse Netherlands 3207 NB
81 GSK Investigational Site Utrecht Netherlands 2584 CX
82 GSK Investigational Site Voerendaal Netherlands 6367 ED
83 GSK Investigational Site Auckland New Zealand 1001
84 GSK Investigational Site Auckland New Zealand 1701
85 GSK Investigational Site Christchurch Hospital New Zealand 8001
86 GSK Investigational Site Alcorcon Spain 28922
87 GSK Investigational Site Barcelona Spain 08003
88 GSK Investigational Site Barcelona Spain 08221
89 GSK Investigational Site Galdakano Spain 48960
90 GSK Investigational Site La Coruña Spain 15006
91 GSK Investigational Site Las Palmas Spain 35020
92 GSK Investigational Site Lugo Spain 27004
93 GSK Investigational Site Madrid Spain 28006
94 GSK Investigational Site Madrid Spain 28041
95 GSK Investigational Site Malaga Spain 29400
96 GSK Investigational Site Valencia Spain 46017
97 GSK Investigational Site Cambridge Cambridgeshire United Kingdom CB3 9HS
98 GSK Investigational Site Saffron Walden Essex United Kingdom CB10 1EJ
99 GSK Investigational Site Barry Glamorgan United Kingdom CF63 4HP
100 GSK Investigational Site Cardiff Glamorgan United Kingdom CF14 9BB
101 GSK Investigational Site Cardiff Glamorgan United Kingdom CF23 5SY
102 GSK Investigational Site Blackpool Lancashire United Kingdom FY1 6JW
103 GSK Investigational Site Blackpool Lancashire United Kingdom FY4 3AD
104 GSK Investigational Site Manchester Lancashire United Kingdom M23 9GP
105 GSK Investigational Site Fleetwood United Kingdom FY7 6HD
106 GSK Investigational Site Fleetwood United Kingdom FY7 7DG

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00479739
Other Study ID Numbers:
  • SAM40056
First Posted:
May 28, 2007
Last Update Posted:
Sep 15, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
formoterol/budesonide
exacerbations
Salmeterol/fluticasone propionate
adjustable maintenance dosing
asthma control
Additional relevant MeSH terms:
Asthma
Fluticasone
Xhance
Budesonide
Formoterol Fumarate
Salmeterol Xinafoate

Study Results

No Results Posted as of Sep 15, 2016