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| Sponsor: | University of Dundee |
|---|---|
| Information provided by: | University of Dundee |
| ClinicalTrials.gov Identifier: | NCT00830505 |
Purpose
The purpose of this study is to compare the effects of Fluticasone/ salmeterol combination and double the dose of fluticasone on airway hyper-responsiveness to methacholine.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: fluticasone/ salmeterol Drug: fluticasone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Cross-Over Study to Demonstrate Superiority of Fluticasone/Salmeterol Over Double the Dose of Fluticasone on Methacholine Hyper-Reactivity in Patients With Persistent, Mild to Moderate Asthma |
| Estimated Enrollment: | 32 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1: fluticasone/salmeterol
2 puffs twice a day for 2 weeks
|
Drug: fluticasone/ salmeterol
2 puffs twice a day for 2 weeks
Other Name: fluticasone/ salmeterol combination
|
|
Active Comparator: 2: fluticasone
2 puffs twice a day for 2 weeks
|
Drug: fluticasone
2 puffs twice a day for 2 weeks
Other Name: Flixotide
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: karine L Clearie, MBBS, MRCP | 01382 496440 ext 36440 | k.clearie@dundee.ac.uk |
| Contact: Brian J Lipworth, MBchB | 01382496440 ext 36440 | brianlipworth@googlemail.com |
| United Kingdom | |
| Asthma and Allergy Research Group | |
| Dundee, Angus, United Kingdom, DD1 9SY | |
| Principal Investigator: | Karine L Clearie, MBBS, MRCP | Asthma and Allergy Research Group |
| Study Director: | Brian J Lipworth, MBchB | Asthma and Allergy Research Group |
More Information
| Responsible Party: | Dr Karine Clearie, Asthma and Allergy Research Group |
| ClinicalTrials.gov Identifier: | NCT00830505 History of Changes |
| Other Study ID Numbers: | CLE001 |
| Study First Received: | January 27, 2009 |
| Last Updated: | January 27, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
fluticasone salmeterol bronchoprotection |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Albuterol Fluticasone Fluticasone, salmeterol drug combination Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Tocolytic Agents Reproductive Control Agents Dermatologic Agents |