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

A Randomized, Open Label, Comparative, Parallel Group, Efficacy and Safety study of Budesonide Dry Powder Inhaler Rotacaps 400 mcg in Patients with Mild to Moderate Asthma - ASIAN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/06/001788

Enrollment

Registered

2011-06-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

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

Interventions

Intervention1: Budecort Rotacaps 400 mcg Budecort Rotacaps 400 mcg: Patients will have to inhale all the powder available in one rotacap (Budesonide Dry Powder Inhaler Rotacaps 400 mcg) two times a

Eligibility

Inclusion criteria

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 Asthma 60-80% 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

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.

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Assessments: 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: i. Forced Expiratory Volume in One Second (FEV1) ii. Peak Expiratory Flow (PEF) Timepoint: Primary Efficacy Assessments: 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: i. Forced Expiratory Volume in One Second (FEV1) ii. Peak Expiratory Flow (PEF)	—

Measure

Time frame

Primary Efficacy Assessments: 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: i. Forced Expiratory Volume in One Second (FEV1) ii. Peak Expiratory Flow (PEF) Timepoint: Primary Efficacy Assessments: 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: i. Forced Expiratory Volume in One Second (FEV1) ii. Peak Expiratory Flow (PEF)

—

Secondary

Measure	Time frame
Secondary Efficacy Assessments: Investigator will evaluate secondary variable for assessing the severity of asthma symptoms by using the 4 point scale from 0 to 3 Safety Assessment: Timepoint: Secondary Efficacy Assessments: Investigator will evaluate secondary variable for assessing the severity of asthma symptoms by using the 4 point scale from 0 to 3	—

Countries

India

Contacts

Public ContactDr Harishkumar Lalan MBBS MD

harishkumar.lalan@raptimresearch.com

Outcome results

None listed

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