NCT02593279

Brief Summary

The aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction. The objective of this study is also to complete the clinical, immunobiological and morphological analysis of asthma with small airways dysfunction.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

4 active sites

Status
terminated

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

October 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

October 28, 2015

Last Update Submit

January 21, 2019

Conditions

ASTHMA

Keywords

Asthmaphenotypesmallairwayproximaldysfunction

Outcome Measures

Primary Outcomes (1)

  • mRNA expression levels.

    mRNA expression levels will be measured by microarray analysis.

    maximum 4 weeks after the inclusion visit.

Secondary Outcomes (11)

  • clinical asthma profile : symptoms

    maximum 4 weeks after the inclusion visit.

  • clinical asthma profile : medical history

    maximum 4 weeks after the inclusion visit.

  • clinical asthma profile : date of start

    maximum 4 weeks after the inclusion visit.

  • clinical asthma profile : date of aggravation

    maximum 4 weeks after the inclusion visit.

  • clinical asthma profile : comorbidities

    maximum 4 weeks after the inclusion visit.

  • +6 more secondary outcomes

Study Arms (2)

asthma with proximal or diffuse lung damage

ACTIVE COMPARATOR
Genetic: asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.

asthma with small airway prevailing damage

EXPERIMENTAL
Genetic: asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.

Interventions

asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.GENETIC

symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, igE analysis, tomodensitometric test.

asthma with proximal or diffuse lung damage
asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.GENETIC

symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, IgE analysis, tomodensitometric test.

asthma with small airway prevailing damage

Eligibility Criteria

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

You may qualify if:

  • man or woman
  • age ≥ 18 years
  • asthma
  • inform consent signed
  • affiliated to health insurance
  • Maximal Voluntary Ventilation (MMV)\<80%
  • MMV / Forced Vital Capacity (FVC)≤70%
  • Carbon Monoxide Transfer Coefficient (KcO)\>80%
  • Maximal Voluntary Ventilation (MMV)≥80%
  • MMV / Vital Capacity(VC)\>70%
  • Carbon Monoxide Transfer Coefficient (KcO)\>80%

You may not qualify if:

  • pregnant woman or breastfeeding
  • patient participating to other biomedical research
  • patient who have participated to other biomedical research within the past 3 months
  • patient refusing to sign the inform consent
  • Patient who stopped smoking since less than 12 months
  • Pathological state related to obstructive distal airway damage
  • Broncho-pulmonary infectious disease within the past 4 weeks
  • Solid tumor curated by chemotherapy or chest radiotherapy
  • Chronic respiratory disease
  • Asthma exacerbation within the past 3 months
  • Oral or systemic corticotherapy within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cabinets de Pneumologie Liberale

Caluire-et-Cuire, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes

Lyon, France

Location

HC pneumo C

Pierre-Bénite, France

Location

MeSH Terms

Conditions

AsthmaCerebral Palsy

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

  • GILLES DEVOUASSOUX, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 2, 2015

Study Start

February 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

FR(4)