CTRI/2025/10/095635Not yet recruitingPhase 3
A multicenter, randomized, double-blind, parallel group, active-controlled Phase III clinical trial to evaluate the efficacy, safety and tolerability of Fixed-Dose Combination of Fluticasone Furoate, Umeclidinium and Vilanterol Dry Powder for Inhalation in comparison with Fixed-Dose Combination of Indacaterol, Glycopyrronium and Mometasone Furoate Powder for Inhalation in subjects with uncontrolled asthma.
Glenmark Pharmaceuticals Ltd.22 sites in 1 country278 target enrollmentStarted: October 17, 2025Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 278
- Locations
- 22
- Primary Endpoint
- Change from baseline in trough FEV1
Study Overview
Brief Summary
This is a multicenter, randomized, double-blind, active-controlled clinical trial to evaluate the efficacy, safety and tolerability of Fixed-Dose Combination of Fluticasone Furoate, Umeclidinium and Vilanterol Dry Powder for Inhalation in comparison with Fixed-Dose Combination of Indacaterol, Glycopyrronium and Mometasone Furoate Powder for Inhalation in subjects with uncontrolled asthma.
Treatments will be administered over a period of 12 weeks, Efficacy will be evaluated using spirometry, asthma control assessment and rescue medication use. Spirometry will be conducted in accordance with the American Thoracic Society (ATS)/European Respiratory Society (ERS) standards. Asthma control will be evaluated using Asthma Control Questionnaire (ACQ) and rescue medication use data will be collected using subject daily diary. The primary outcome measures consist of change from baseline in in trough FEV1 at week 12.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and female subjects with age greater than 18 years and less than 65 years (subjects who have celebrated their 18th birthday and have not yet celebrated 65th birthday will be included).
- •Provided written informed consent and are willing to and able to comply with all aspects of the protocol.
Exclusion Criteria
- •Any asthma exacerbation requiring a change in maintenance asthma therapy in the 12 weeks prior to screening visit.
- •Evidence of a moderate-to-severe exacerbation during screening or run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
- •Subjects with a diagnosis of chronic obstructive pulmonary disease (COPD).
- •Subjects who are: • Current smokers (defined as subjects who have used inhaled tobacco products within the 12 months prior to screening visit [i.e., cigarettes, bidi, e-cigarettes/vaping, cigars or pipe tobacco]).
- •• Former smokers with a smoking history of greater than or equal to 10 pack years (e.g. 20 cigarettes per day for 10 years).
- •Subjects receiving triple therapy with ICS, LABA and long-acting muscarinic antagonist (LAMA) as fixed combination or concomitantly.
- •Subjects with current evidence or history of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
- •Patients at potentially high risk (e.g. very low body mass index [BMI], severely malnourished, or very low FEV1) will only be included at the discretion of the investigator.
- •Subjects with historical or current evidence or history of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
- •Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- •Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- •Evidence of clinically significant abnormal laboratory tests during screening or run-in which are still abnormal upon repeat analysis (if performed based on investigator’s opinion) and are not believed to be due to disease(s) present.
- •Each investigator will use his/her own discretion in determining the clinical significance of the abnormality.
- •Antimuscarinic effects: Subjects with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the investigator the benefit outweighs the risk and that the condition would not contraindicate study participation.
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- •Pregnant or breastfeeding.
Outcomes
Primary Outcomes
Change from baseline in trough FEV1
Time Frame: At Week 12
Secondary Outcomes
- Change from baseline in FEV1 area under the curve from time 0 to 2 hours (AUC0-2h)([Time Point: at Day 1 and week 12])
- Change from baseline in peak FEV1([Time at week 4 and week 12])
- Change from baseline in trough FEV1([Time at week 4 and week 12])
- Change from baseline in asthma control questionnaire-7 (ACQ-7) score([Time at week 4, week 8, and week 12])
- Percent rescue medication free days([Time Point: Over 12-week treatment period])
Investigators
Study Sites (22)
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