NCT01360294

Brief Summary

The aim of this study is to develop a patient reported outcome tool specific to small airways disease, which assesses symptoms and signs of small airways disease and may help in addition to FEF50% to discriminate between asthmatic patients with and without small airways disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 12, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

May 12, 2011

Last Update Submit

June 27, 2013

Conditions

Asthma

Keywords

AsthmaSmall airways diseaseQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Symptoms associated with small airways disease

    A questionnaire based on symptoms to discriminate between asthmatic patients with and without small airways disease.

    1 year

Study Arms (2)

Asthma with small airway disease

Asthma without small airway disease

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will contain a total of 60 adult patients with asthma, 30 patients with small airways disease and 30 patients without small airways disease.

You may qualify if:

  • A doctor diagnosis of asthma
  • Age: ≥ 18 and ≤ 75 years
  • An FEF50% value that is included in either the lowest or the highest 25th percentile. (Percentiles based on the total asthma patient group present from Asthma/COPD service)

You may not qualify if:

  • Recent exacerbation of asthma (\<2 months) or upper respiration tract infection (\<2 weeks)
  • Severe airway obstruction at baseline, FEV1pred\< 50% or \< 1.2L
  • Diagnosis of COPD or another pulmonary disease
  • Pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator).
  • Restriction, defined as FVC \< 80%pred with FEV1/FVC \>0.7

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 25, 2011

Study Start

September 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations

NL(1)