Clinical safety and efficacy study in asthmatic patients who use Salmeflo Inhaler

Phase 3

• Conditions: Asthma.; Asthma , Status asthmaticus; J45 , J46

• Registration Number: IRCT2014083014727N5
• Lead Sponsor: Sadaf Darou Saba Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Patients aged 18 years and older who are willing to participate and sign a consent form; Patients who have the ability of using the inhaler with correct technique;
exclusion criteria: Using of Inhaled Corticosteroid or Long Acting Beta Agonist in the last month before entering the study; patients with known hypersensitivity to Beta 2 agonist or Inhaled Corticosteroid; patients with lower respiratory system's infection (abnormal chest X ray) during the study; Alcoholics, drugs abuser; Patients who are pregnant or breastfeeding; Patients who use drug for another asthma trial; Patients with another severe and uncontrolled chronic disease, such as Heart failure, FC III, IV and history of myocardial infarction; Patients who show symptoms of acute reactions during the study; Non-compliance patient with treatment protocols; Requiring to use oxygen or systemic corticosteroid during the study; Disability to record the use of rescue medication accurately.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of averages of FEV1. Timepoint: Before study, Every 4 weeks after study. Method of measurement: by Spirometry.;Comparision of disease management. Timepoint: Before Study, Every 4 weeks after study. Method of measurement: ACT query.