Comparison of Anti-inflammatory Effects of Seroflo and Seretide in Patients With Asthma
This study is enrolling participants by invitation only.
Sponsor:
Mahidol University
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01274325
First received: January 7, 2011
Last updated: July 21, 2011
Last verified: July 2011
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Purpose
The purpose of this study is to test hypothesis if Sereflo (ICS/LABA) could reduce airway inflammation in asthmatic patients in the same as Seretide.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Sereflo Drug: Seretide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Anti-inflammatory Effects of Seroflo 125 Inhaler With Seretide Evohaler(25/125) in Patients With Asthma |
Resource links provided by NLM:
Further study details as provided by Mahidol University:
Primary Outcome Measures:
- Sputum eosinophils [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Exhaled nitric oxide [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Asthma control test scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sereflo
Sereflo (25/125)
|
Drug: Sereflo
Patients take sereflo (25/125) 2 puffs twice a day for 4 weeks
|
|
Active Comparator: Seretide
Seretide (25/125)
|
Drug: Seretide
Patients will take Seretide (25/125) 2 puffs twice a day for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age between 20-80 years
- Patients with asthma diagnosed by according to the American Thoracic Society criteria
- A baseline FEV1 > or = 50% predicted with a reversibility of FEV1 after therapy with inhaled salbuterol (2.5 mg) of FEV1 12% or with provocative concentration of a methacholine causing a 20% fall in FEV1 (PC20) of < or = 8 mg/mL
- Prescribed use of inhaled corticosteroids (any brand) for at least 12 weeks prior to study entry
- The daily prescribed dose of inhaled corticosteroids during the last 4 weeks prior to study entry should have been constant and at least 250 μg/day of fluticasone at least 400 μg/day of budesonide at least 500 μg/day of any other beclomethasone
- Be able to provide written informed consent
Exclusion Criteria:
- Any asthma exacerbation or respiratory tract infection affecting asthma within 4 weeks prior to the randomization visit
- Intake of oral, parenteral corticosteroids within 4 weeks and/or depot parenteral corticosteroid within 12 weeks prior to the randomization visits
- Current or previous smoker with a smoking history of > or = 10 pack years
- Previous randomization of treatment in the present study
- Known or suspected hypersensitivity to study therapy
- Use of any β-blocking agent, including eye-drops
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive pill measures
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274325
Locations
| Thailand | |
| Kittipong Maneechotesuwan | |
| Bangkoknoi, Bangkok, Thailand, 10700 | |
| Division of Respiratory Disease and TB, Siriraj Hospital | |
| Bangkoknoi, BKK, Thailand, 10700 | |
Sponsors and Collaborators
Mahidol University
Investigators
| Principal Investigator: | Kittipong Maneechotesuwan, MD., PhD. | Faculty of Medicine Siriraj Hospital |
More Information
No publications provided
| Responsible Party: | Kittipong Maneechotesuwan, Faculty of Medicine Siriraj Hospital |
| ClinicalTrials.gov Identifier: | NCT01274325 History of Changes |
| Other Study ID Numbers: | si446/2010 |
| Study First Received: | January 7, 2011 |
| Last Updated: | July 21, 2011 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Mahidol University:
|
asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Anti-Inflammatory Agents |
Fluticasone, salmeterol drug combination Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on October 18, 2012
