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

Comparison of the efficacy and safety of Salmeflo and Seretide in patients with asthma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014083014727N5
Enrollment
96
Registered
2014-12-23
Start date
2014-11-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma. Asthma , Status asthmaticus

Interventions

Intervention 1: Intervention group: Salmeflo 125/25 , 2 puffs BID. Intervention 2: Control group: Seretide 125/25, 2 puffs BID.
Treatment - Drugs
Intervention group: Salmeflo 125/25 , 2 puffs BID
Control group: Seretide 125/25, 2 puffs BID

Sponsors

Sadaf Darou Saba Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ronak Saadati

Sadaf Darou Saba Company

r.saadati@sadafdarousaba.com; f.shahrokhi@sadafdarousaba.com+98 21 8854 7515

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026