Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
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ClinicalTrials.gov Identifier: NCT00291382 |
Recruitment Status :
Completed
First Posted : February 14, 2006
Last Update Posted : May 30, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Salmeterol/fluticasone propionate combination | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multicentre, Stratified, Randomised, Double Blind, Parallel Group Trial to Evaluate Whether a Treatment Strategy Based on Aiming for Total Control Results in Better AHR Than a Treatment Strategy Based on Maintaining Well Control |
Actual Study Start Date : | November 2005 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | July 2007 |

- Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.
- Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- History of asthma of at least 6 months.
- Subjects who have received fluticasone propionate at a dose of 100 mcg bd to 250 mcg bd or equivalent with or without a long acting beta2-agonist for at least 4 weeks before the start of the run-in period, at a constant dose.
- Subjects who are able to understand and complete an electronic diary card.
Exclusion criteria:
- Subjects who have been hospitalized for their asthma within 4 weeks of study entry.
- Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to study entry.
- Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to study entry.
- Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function.
- Subjects who have more than 5 pack years.
- Subjects who currently smoke.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291382
Belgium | |
GSK Investigational Site | |
Gent, Belgium, 9000 | |
GSK Investigational Site | |
Liège, Belgium, 4000 | |
Estonia | |
GSK Investigational Site | |
Tartu, Estonia, 51014 | |
Finland | |
GSK Investigational Site | |
Jyvaskyla, Finland, 40100 | |
GSK Investigational Site | |
Tampere, Finland, 33100 | |
France | |
GSK Investigational Site | |
Lille cedex, France, 59042 | |
GSK Investigational Site | |
Montpellier, France, 34295 | |
GSK Investigational Site | |
Poitiers, France, 86000 cedex | |
Germany | |
GSK Investigational Site | |
Sinsheim, Baden-Wuerttemberg, Germany, 74889 | |
GSK Investigational Site | |
Bonn, Nordrhein-Westfalen, Germany, 53123 | |
GSK Investigational Site | |
Berlin, Germany, 10559 | |
GSK Investigational Site | |
Berlin, Germany, 13353 | |
GSK Investigational Site | |
Berlin, Germany, 13359 | |
Italy | |
GSK Investigational Site | |
Torrette (AN), Marche, Italy, 60020 | |
GSK Investigational Site | |
Foggia, Puglia, Italy, 71100 | |
GSK Investigational Site | |
Cagliari, Sardegna, Italy, 09126 | |
GSK Investigational Site | |
Pisa, Toscana, Italy, 56124 | |
GSK Investigational Site | |
Bussolengo (VR), Veneto, Italy, 37012 | |
GSK Investigational Site | |
Salerno, Italy, 84100 | |
Latvia | |
GSK Investigational Site | |
Riga, Latvia, LV 1003 | |
GSK Investigational Site | |
Riga, Latvia, LV 1035 | |
Netherlands | |
GSK Investigational Site | |
Breda, Netherlands, 4819 EV | |
GSK Investigational Site | |
Groningen, Netherlands, 9721 SW | |
GSK Investigational Site | |
Harderwijk, Netherlands, 3844 DG | |
GSK Investigational Site | |
Helmond, Netherlands, 5707 HA | |
GSK Investigational Site | |
Hoorn, Netherlands, 1624 NP | |
GSK Investigational Site | |
Nieuwegein, Netherlands, 3435 CM | |
GSK Investigational Site | |
Veldhoven, Netherlands, 5504 DB | |
Spain | |
GSK Investigational Site | |
Barcelona, Spain, 08022 | |
GSK Investigational Site | |
Madrid, Spain, 28006 | |
GSK Investigational Site | |
Tarrasa, Barcelona, Spain, 08221 | |
GSK Investigational Site | |
Valencia, Spain, 46017 | |
Sweden | |
GSK Investigational Site | |
Göteborg, Sweden, SE-413 45 | |
GSK Investigational Site | |
Linköping, Sweden, SE-585 81 | |
GSK Investigational Site | |
Lund, Sweden, SE-221 85 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00291382 |
Other Study ID Numbers: |
SAM49071 |
First Posted: | February 14, 2006 Key Record Dates |
Last Update Posted: | May 30, 2017 |
Last Verified: | May 2017 |
Total asthma control airway hyper-responsiveness adult Asthma |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Salmeterol Xinafoate Anti-Inflammatory Agents Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |