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NCT02811315 Clinical Trial

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

Asthma Clinical Trial

Official title:
Flutiform Treatment in Patients With Asthma in Daily Clinical Practice; a Prospective Observational Non-interventional Study Assessing the Effect of Space Use and Adherence on Fluticasone/Formoterol FDC Efficacy Measured With the Asthma Control Questionnaire (ACQ-6).

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02811315
Other study ID # FLT9509
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 2016
Est. completion date December 15, 2016

Study information
Verified date November 2018
Source Mundipharma Pharmaceuticals B.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 15, 2016
Est. primary completion date December 15, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Observational. Non interventional study
Observational. Non interventional study

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mundipharma Pharmaceuticals B.V.

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the effect of frequency of spacer use on asthma control in patients in normal clinical practice 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. This measurement will be taken after 12 weeks of treatment
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