A clinical trial to assess the efficacy and safety of Formoterol fumarate and Fluticasone propionate powder for inhalation (Formoflo 250) in the patients withAsthma

Phase 4

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

• Registration Number: CTRI/2023/08/056250
• Lead Sponsor: upin Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients of either gender between 18-65 years of age (both inclusive)

2. Patients with mild to moderate asthma not receiving any regular

controller medication since last 12 weeks

3. Patients with bronchodilator reversibility i.e., increase in FEV1 of >= 12% and >= 200 ml after salbutamol inhalation at screening

4. Pre-bronchodilator FEV1 of 60% to 85% of the predicted normal value at screening

5. Patients with Asthma Control Test (ACT) score <= 15 at screening

6. Patients willing to provide written informed consent and comply with the

protocol requirements

Exclusion Criteria

1. Known hypersensitivity to any β2-agonist, sympathomimetic drug, or any

inhaled, intranasal or systemic corticosteroid

2. History of life-threatening asthma within past 5 years prior to screening

3. Asthma exacerbation requiring systemic corticosteroids or that resulted in

hospitalization within 6 months prior to screening

4. Patients diagnosed with COVID-19 within 3 months prior to screening

5. Suspected or confirmed bacterial or viral infection of the upper or lower

respiratory tract, sinus or middle ear within 4 weeks prior to screening

6. Patients with concurrent respiratory disorder other than asthma such as but

not limited to pneumonia, pulmonary tuberculosis, chronic bronchitis, chronic

obstructive pulmonary disease, pneumothorax, atelectasis,

bronchopulmonary dysplasia, interstitial lung disease, cystic fibrosis

7. Clinical evidence of oropharyngeal candidiasis at screening

8. Patients with clinically significant uncontrolled systemic diseases such as

cardiovascular, renal, neurological, psychiatric, endocrine, immunological or

hematological disorders or malignancy

9. Patients with hepatic dysfunction (serum transaminases >= 3 x Upper Normal

Limit) or renal dysfunction (serum creatinine

10. >= 2.5 mg/dl) at screening

11. Patients who have used prohibited medications

12. Pregnant or Lactating females; or female patients of childbearing potential

unwilling to use effective contraception

13. Current smokers or ex-smokers who have stopped smoking within 6 months

prior to screening or have a smoking history of at least 10 pack-years

14. Patients with continuing history of alcohol and/or drug abuse

15. Participation in another clinical trial within 3 months prior to screening

16. Any other reason for which the investigator feels that the patient should not

participate

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in trough FEV1Timepoint: From Baseline (Day 0) to end of month 3 & 6.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in trough FVC & ACT score & Asthma Quality of Life Questionnaire (AQLQ) scoreTimepoint: Baseline (Day 0) to month 3 & 6.;Number of adverse events, Serious adverse events & Asthma exacerbations reported during the studyTimepoint: From Baseline to end of study