A study to assess the control of asthma and ease of use of inhaler device (Synchrobreathe) with the medicine (Seroflo-Salmetrol/Fluticasone FDC) in routine clinical practice

An Open Label, Observational, Prospective, Non-Comparative, Multicentre Study to Evaluate Asthma Control and Device Usability of Salmeterol/Fluticasone Propionate FDC Administered Through Synchrobreathe in Patients with Persistent Asthma - EVOLVE Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/12/016629

Enrollment

500

Registered

2018-12-12

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: J709- Respiratory conditions due to unspecified external agent

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. A voluntarily given, written signed dated informed data sharing consent from patients and/or legally acceptable representative 2. Patients of either gender of age 12 years and above 3. Subjects with documented diagnosis of asthma who are treatment naÃ¯ve or uncontrolled due to poor inhaler technique 4. Able and willing to comply with all study requirements 5. Patients suitable for study as per Investigator and eligible to start treatment with Salmeterol/Fluticasone FDC administered through Synchrobreathe

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to study drug and/or its components 2. Acute episode of asthma where intensive measures were used or primary treatment of status asthmaticus 3. Patients experienced with the use of Synchrobreathe device

Design outcomes

Primary

Measure	Time frame
Change in Asthma Control Questionnaire-6 (ACQ-6) ScoreTimepoint: at week 4 and week 8 from baseline	—

Secondary

Measure	Time frame
â?¢ Assessment of Device usability questionnaireTimepoint: at week 4;â?¢ Change in Asthma Control Questionnaire-6 (ACQ-6) Score at week 4 and week 8 from baselineTimepoint: at week 4 and week 8 from baseline;â?¢ Change in PEFR scoreTimepoint: at week 4, week 8 and week 12 from baseline;â?¢ Proportion of patients as responders (improvement ACQ-6 more than 0.5); well-controlled (ACQ-6 less than 0.75), partially controlled (more than 0.75 ACQ-6 less than 1.5), and uncontrolled (ACQ-6 more than 1.5)Timepoint: at week 4 and week 8 from baseline	—

Measure

Time frame

â?¢ Assessment of Device usability questionnaireTimepoint: at week 4;â?¢ Change in Asthma Control Questionnaire-6 (ACQ-6) Score at week 4 and week 8 from baselineTimepoint: at week 4 and week 8 from baseline;â?¢ Change in PEFR scoreTimepoint: at week 4, week 8 and week 12 from baseline;â?¢ Proportion of patients as responders (improvement ACQ-6 more than 0.5); well-controlled (ACQ-6 less than 0.75), partially controlled (more than 0.75 ACQ-6 less than 1.5), and uncontrolled (ACQ-6 more than 1.5)Timepoint: at week 4 and week 8 from baseline

—

Countries

India

Contacts

Public ContactMr Abhijit Vaidya

Cipla Ltd.

sandesh.sawant3@cipla.com02223025186

Outcome results