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Comparison of The Anti-inflammatory Effect between Original and Generic Salmeterol/Fluticasone propionate Combination Treatment in Asthmatic patient

Comparison of The Anti-inflammatory Effect between Original and Generic Salmeterol/Fluticasone propionate Combination Treatment in Asthmatic patient

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260327004
Enrollment
20
Registered
2026-03-27
Start date
2025-05-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Asthmatic patients without currently treatment Asthma, ICS/LABA, Airway inflammation, FeNO

Interventions

2 puffs twice daily of generic drug,2 puffs twice daily of original drug
Experimental Drug,Active Comparator Drug
Generic drug,Original drug

Sponsors

AeroCare And Inpac Pharma
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with asthma who have not been treated with medicine, have stopped using medicine for more than 3 months, or have been diagnosed with a new asthma patient. (If there is no lung function test result may use clinical symptoms instead) 2. Do not smoke or have smoked for no more than 10-pack-years.

Exclusion criteria

Exclusion criteria: 1. Moderate to severe exacerbation within 1 month 2. History of respiratory tract infection within 1 month 3. Pregnancy 4. Using oral corticosteroid 5. Contraindication to be performed pulmonary function test

Design outcomes

Primary

MeasureTime frame
Airway inflamation 4 weeks Exhale of nitric oxide (The change in number of level; ppb),Lung function 4 weeks Force expiratory volum in 1 second,Asthma control 4 weeks Asthma control test (Changing in ACT score or ACQ score),Anti-inflammatory response 4 weeks Absolute blood eosinophil count

Secondary

MeasureTime frame
Side effect 4 weeks Self reported ( oral candidiasis, horseness, drug allerg, exacerbation of symptoms)

Countries

Thailand

Contacts

Public ContactSiwadol Sunhapanit

Vajira hospital

siwadol.sun@nmu.ac.th0841070229

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026