A Study to check the effect of of two doses of mometasone furoate delivered via Concept1 or Twisthaler® in adult and adolescent patients with persistent asthma

Phase 2

Recruiting

• Conditions: Health Condition 1: null- adult and adolescent patients with persistent asthma

• Registration Number: CTRI/2013/01/003296
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 616

Inclusion Criteria

Main Key Inclusion Criteria are as follows:

•Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:

•Patients who are receiving ICS treatment

•Patients whose level of asthma control is Partly Controlled or Uncontrolled

•Patients with a pre-bronchodilator FEV1 value of less than or equal to 80% of predicted normal value

•Patients who demonstrate an increase of more than or equal to 12% and 200 mL in FEV1

•Patients who are confirmed as ICS sensitive by ACQ-5 questionnaire and FEV1

Other protocol-defined inclusion criteria are also applied.

Exclusion Criteria

Main Key Exclusion Criteria are as follows:

•Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).

•Patients diagnosed with COPD as defined by the GOLD 2010 guidelines.

•Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.

•Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

Other protocol-defined Exclusion criteria are also applied.

Study & Design

• Study Type: Interventional
• Study Design: Not specified