Flutiform in Treatment of Patients With Asthma in Daily Clinical Practice.

Withdrawn

• Conditions: Asthma

• Registration Number: NCT02811315
• Lead Sponsor: Mundipharma Pharmaceuticals B.V.

Brief Summary

The objective of the study is to evaluate the effect of frequency of use with a spacer on asthma control in Dutch patients with asthma during their daily clinical practice over 12 weeks treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-23
• Study Start: 2016-07
• Primary Completion: 2016-12-15
• Study Completion: 2016-12-15
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-14
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows:

Patients not adequately controlled in inhaled corticosteriods and "as required" inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist.

The decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study

Exclusion Criteria

• There are no specific exclusion criteria as this is an observational study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of frequency of spacer use on asthma control in patients in normal clinical practice	This measurement will be taken after 12 weeks of treatment	the Asthma Control Questionnaire will be completed by subjects at study baseline and then after 12 weeks of treatment. Difference between the 2 will be the primary endpoint.