Comparative Study of the Efficacy and Safety of Budesonide, Inhalation Powder, Capsule 400 μg/dose

Phase 3

Not yet recruiting

• Conditions: In patients with partially controlled asthma

• Registration Number: CTRI/2017/02/007787
• Lead Sponsor: Rus Biopharm LLC

Brief Summary

This study is designed as an open-label, multicentre, randomized, comparative trial.

The total duration of the study for each patient will not exceed 109 days, of which the duration of screening will not exceed 14 days, the duration of the treatment period 84 days, and the duration of the follow-up period 11 days.

Before the screening, the patient will be informed about this clinical study and the rules of participation in the study. If a patient consents to participate in this study, he / she will sign the Informed Consent Form in the Patient Information Leaflet. The Investigator will ask every patient to provide information on his / her mobile and home (if applicable) telephone numbers, as well as the telephone number of a contact person who can be contacted in case of impossibility of communication with the patient. After the signing of the Informed Consent Form in the Patient Information Leaflet, the patient will be enrolled in the study. The Investigator will assign a three-digit screening number to the patient. At each study site, patients will receive their screening numbers as they are enrolled in the study. The screening number will be recorded in the Study Screening Log and on the title page of the Case Report Form (CRF). After the screening procedures (see Section 6.8), patients who meet all inclusion criteria and do not meet any exclusion criteria will continue their participation in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-15
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Diagnosis of persistent asthma established according to the GINA guidelines (2015) not less than 6 months prior to the screening visit Asthma inadequately controlled with inhaled glucocorticoids (IGC) and short-acting beta-agonists (SABA) as on-demand therapy ACQ-5 score ≥ 0.75 and < 1.5. Forced expiratory volume in 1 second (FEV1) prior to administration of bronchodilators not less than 60 % of the due value.
• Availability of a signed and dated Informed Consent Form for participation in the study.

Exclusion Criteria

• Contraindications for treatment with inhaled IC, hypersensitivity to budesonide, salbutamol, or to any other ingredient included in the formulation of salbutamol. Galactose intolerance, lactase deficiency, or glucose.
• galactose malabsorption. Body mass index (BMI) > 35 kg/m2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Magnitude of the increase in FEV1	at Visits 1, 2, and 4 before the inhalation and the use of SABAs

Secondary Outcome Measures

Name	Time	Method
FEV1 changes	Visit 2, 3, 4
Changes in absolute PEF	Visit 2, 3, 4
Total ACQ-5 (asthma control questionnaire) score changes	Visit 2, 3, 4
SF-36 (quality of life questionnaire) score changes	Visit 2 and Visit 4
Proportion of patients achieving asthma control	Visit 4
Weekly average daily SABA requirement	Visit 2, 3, 4
Proportion of patients with exacerbated disease	Visits 2, 3, and 4

Trial Locations

Locations (1)

Hi Tech Medical College & Hospital; 🇮🇳 Cuttack, ORISSA, India

Hi Tech Medical College & Hospital

🇮🇳Cuttack, ORISSA, India

Dr Sarat Kumar Behera

Principal investigator

9439129178

behera.saiprasanna82@gmail.com