Comparison of Anti-inflammatory Effects of Seroflo and Seretide in Patients With Asthma

Asthma Clinical Trial

Official title:

Comparison of Anti-inflammatory Effects of Seroflo 125 Inhaler With Seretide Evohaler(25/125) in Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274325
• Other study ID #: si446/2010
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2011
• Last updated: September 9, 2013
• Start date: February 2011
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ß-blocking agent, including eye-drops

• Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive pill measures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Sereflo
Patients take sereflo (25/125) 2 puffs twice a day for 4 weeks
• Seretide
Patients will take Seretide (25/125) 2 puffs twice a day for 4 weeks

Locations

Country	Name	City	State
Thailand	Division of Respiratory Disease and TB, Siriraj Hospital	Bangkoknoi	BKK
Thailand	Kittipong Maneechotesuwan	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum eosinophils		4 weeks	No
Secondary	Exhaled nitric oxide		4 weeks	No
Secondary	Asthma control test scores		4 weeks	No