NCT02811315

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

June 21, 2016

Last Update Submit

November 14, 2018

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Observational. Non interventional studyOTHER

Observational. Non interventional study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 23, 2016

Study Start

July 1, 2016

Primary Completion

December 15, 2016

Study Completion

December 15, 2016

Last Updated

November 16, 2018

Record last verified: 2018-11