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To know whether the newer drug combination i.e. Vilanterol-Fluticasone is better than the conventionally use combination Formoterol-Budesonide in terms of effectiveness in controlling asthma symptoms and improving lung function in stable asthma patients or not.

Efficacy of Vilanterol- Fluticasone Furoate versus Formoterol-Budesonide combination therapy in stable asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052174
Enrollment
90
Registered
2023-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: J453- Mild persistent asthma Health Condition 2: J454- Moderate persistent asthma

Interventions

Intervention1: Group A (Case group): Stable asthma patients on inhalational formoterol-budesonide combination therapy for past 12 weeks will be randomised into 2 groups - Group A (Case group) and Grou

Sponsors

Department of Pulmonary, Critical Care and sleep Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Stable asthma patients on formoterol-budesonide combination with following eligibility criteria: 1. >18 years of age 2. On Formoterol- budesonide therapy for atleast >12 weeks prior to enrollment

Exclusion criteria

Exclusion criteria: ¬Uncontrolled asthma patient (ACT score ¬Severe refractory asthma ¬Patients with history of acute exacerbation of Asthma in the preceding 6 weeks ¬Patient with known or suspected allergy to VI-FF ¬Asthma patients with other respiratory co-morbidities like COPD, lung cancer and interstitial lung disease. Patients who are not able to perform spirometry

Design outcomes

Primary

MeasureTime frame
To compare the change in FEV1 after 8 weeks of vilanterol-fluticasone furoate versus formoterol-budesonide combination therapy. Timepoint: All patients will be evaluated at Day 0 ( day of enrolment) and at 4th and 8th week to assess improvement in asthma symptoms.—

Secondary

MeasureTime frame
To compare the change in ACT (Asthma control test) after 8 weeks of vilanterol-fluticasone furoate versus formoterol-budesonide combination therapy. Timepoint: All patients will be evaluated at Day 0 ( day of enrolment) and at 4th and 8th week.—

Countries

India

Contacts

Public ContactDr Aamir Shokat

Government Medical College And Hospital, Chandigarh

varindersaini62@gmail.com9646121622

Outcome results

None listed

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