A clinical trial to study the efficacy and safety of Budesonide Dry Powder Inhaler Rotacaps in Patients with Mild to Moderate Asthma.

Phase 3

• Conditions: Health Condition 1: null- Patients with Mild to Moderate Asthma

• Registration Number: CTRI/2011/06/001788
• Lead Sponsor: Inventia Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

i)Patients of either sex between 18 to 65 years with a diagnosis of mild to moderate persistent asthma (minimum duration, 6 months)

Type of Asthma% FEV1 (Forced Expiratory Volume in One Second)

Mild Asthma¡Ý 80%

Moderate Asthma60-80%

ii)Patient who inhaled corticosteroids at a constant dose (200 to 500 mcg/day) for at least 1 month prior to inclusion in the study will be enrolled.

Exclusion Criteria

i) Use of oral, parenteral, or rectal corticosteroids within 30 days of study commencement.

ii)Respiratory infection affecting disease control within the previous 4 weeks.

iii)Known hypersensitivity to Budesonide.

iv)Patients with severe cardiovascular disorders or other pulmonary diseases.

v)Current and Ex-smokers with a history of smoking for ¡Ý 10 pack-years.

vi)Pregnant or lactating females or women of childbearing potential without any efficient contraception.

vii)Seasonal asthma or asthma occurring only during episodic exposure to an allergen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Assessments: <br/ ><br>Investigator will evaluate following primary variables for assessing efficacy using Spirometer on day 1 (baseline i.e. prior to drug administration), day 7, day 14, day 21 and day 28: <br/ ><br>i.Forced Expiratory Volume in One Second (FEV1) <br/ ><br>ii.Peak Expiratory Flow (PEF) <br/ ><br>Timepoint: Primary Efficacy Assessments: <br/ ><br>Investigator will evaluate following primary variables for assessing efficacy using Spirometer on day 1 (baseline i.e. prior to drug administration), day 7, day 14, day 21 and day 28: <br/ ><br>i.Forced Expiratory Volume in One Second (FEV1) <br/ ><br>ii.Peak Expiratory Flow (PEF) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Assessments: <br/ ><br>Investigator will evaluate secondary variable for assessing the severity of asthma symptoms by using the 4 point scale from 0 to 3 <br/ ><br>Safety Assessment: <br/ ><br>Timepoint: Secondary Efficacy Assessments: <br/ ><br>Investigator will evaluate secondary variable for assessing the severity of asthma symptoms by using the 4 point scale from 0 to 3 <br/ ><br> <br/ ><br>