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

November 14, 2018 updated by: Mundipharma Pharmaceuticals B.V.

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).

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma Pharmaceuticals B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2016

Primary Completion (Anticipated)

December 15, 2016

Study Completion (Anticipated)

December 15, 2016

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLT9509

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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