Health Condition 1: null- Patients with persistent asthma
Conditions
Interventions
Intervention1: Fluticasone/Formoterol (Maxiflo®) FDC Rotacaps taken through Revolizer: Fluticasone/Formoterol (Maxiflo®) FDC Rotacaps. Dose:100/6 mcg and 250/6 mcg taken through Revolizer manufactur
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Asthma control testâ?¢ (ACT)Timepoint: Mean change in Asthma control testâ?¢ (ACT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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: ï?¢ Change in dose of ICS-LABA combination ï?¢ Addition of theophylline or Leukotriene antagonist or any other medications ï?¢ Change in ICS-LABA combination ï?¢ 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 | — |
Countries
India
Contacts
Public ContactMr Satish Marukurti
Cipla Ltd.
Outcome results
None listed