An observational real world effectiveness study of Fluticasone/Formoterol FDC(Maxiflo®)Rotacaps(100/6 mcg and 250/6 mcg) when taken through Revolizer® inpatients with persistent Asthma

Phase 4

Completed

• Conditions: Health Condition 1: null- Patients with persistent asthma

• Registration Number: CTRI/2014/11/005164
• Lead Sponsor: Cipla Ltd

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: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1. Patients and/or LAR willing to give voluntarily signed informed consent.

2. Patients of both the sex above 18 years of age.

3. Confirmed diagnosis of asthma (As per Revised GINA 2012) and able to

use the Breath-o-meter® and Revolizer®dry powder inhaler correctly.

4. Patients who are already prescribed Fluticasone/Formoterol (Maxiflo®) at

any dose through Revolizer® (dry powder inhaler device) as a part of

standard of care based upon asthma severity or patients who are

uncontrolled on other treatment through Revolizer® and requires a change

in their treatment to Fluticasone/Formoterol FDC as per treating physicians

discretion.

Exclusion Criteria

1. Any chronic respiratory disease other than asthma.

2. Known or suspected hypersensitivity to combination or any other

constituent of Fluticasone/FormoterolFDCRotacaps.

3. On any medication documented to have a drug interaction with

Fluticasone/FormoterolFDC.

4. Females who are pregnant, lactating or planning to become pregnant

5. Patients who are scheduled to receive any other investigational drug during

the course of the study

6. Treatment with any investigational drug in last 30 days prior to

screeningvisit 1.

7. Patients having a smoking history of >= 10 pack years.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in Asthma control testâ?¢ (ACT)Timepoint: Mean change in Asthma control testâ?¢ (ACT)

Secondary Outcome Measures

Name	Time	Method
Mean change in morning and evening PEFR measured using Breath-o-meter® device)Timepoint: At the end of 4, 8, 16 and 24 weeks compared to visit 1;Number & severity (hospitalisation/oral steroids) of Exacerbations recordedTimepoint: At the end of 24 weeks treatment;Number of patients having symptom free days and nightsTimepoint: At all the visits;Number of patients requiring any Change from study medication: <br/ ><br>� Change in dose of ICS-LABA combination <br/ ><br>� Addition of theophylline or Leukotriene antagonist or any other <br/ ><br>medications <br/ ><br>� Change in ICS-LABA combination <br/ ><br>� Change of inhaler deviceTimepoint: At any visit;Response to device UPSC (usability/Preference/satisfaction/confidence) 2014 questionnaire (parameters which will help in determining efficacy of the Revolizer)Timepoint: After 1 week