NCT02558127

Brief Summary

The combination of asthma and being a carrier of genetic variants (mutations and / or polymorphisms) in the CFTR gene variant would cause bronchial asthma with mucus hypersecretion. This phenotype is characterized by a more severe disease, in terms of control, quality of life, exacerbations and lung function, and a different asthma the bronchial hypersecretion without inflammatory phenotype.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

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

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 19, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

June 15, 2015

Last Update Submit

October 18, 2016

Conditions

Asthma

Keywords

asthmacystic fibrosis

Outcome Measures

Primary Outcomes (1)

  • Number of asthmatic patients CF carriers

    12 months

Secondary Outcomes (1)

  • Noncarriers number of asthmatics

    12 months

Study Arms (2)

50 asthma patients

50 asthma patients with bronchial mucus hypersecretion

Genetic: Asthma patients

asthma patients

50 asthma patients without bronchial mucus hypersecretion

Genetic: Asthma patients

Interventions

Asthma patientsGENETIC

Patients with inclusion criteria, following examinations: a study of lung function measurement of the fraction of nitric oxide in exhaled air, induced sputum, sputum, and extraction of peripheral venous blood for Study of genetic variants in the CFTR gene,skin prick test . The number of eosinophils in peripheral blood by automated cell counting and Total IgE by ELISA were measured. Furthermore, the level of asthma control be assessed by validated symptom questionnaire Asthma Control Test, quality of life is determined by the MiniAQLQ questionnaire.

50 asthma patientsasthma patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 100 asthmatic patients of both sexes, aged between 18 and 80 years will be included in the study. They have not a respiratory infection in the last month. Of the 100 patients, 50 will be hypersecretory asthmatic patients and 50 non- hypersecretory asthmatic patients. Both groups have an even distribution regarding sex, age, level and disease control. Asthma patients were defined according to the criteria of the GEMA 2015 -GINA 2014

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

Barcelona, Barcelona, 08041, Spain

Location

Related Publications (3)

  • Goodwin J, Spitale N, Yaghi A, Dolovich M, Nair P. Cystic fibrosis transmembrane conductance regulator gene abnormalities in patients with asthma and recurrent neutrophilic bronchitis. Can Respir J. 2012 Jan-Feb;19(1):46-8. doi: 10.1155/2012/546702.

    PMID: 22332135RESULT

  • Dahl M, Tybjaerg-Hansen A, Lange P, Nordestgaard BG. DeltaF508 heterozygosity in cystic fibrosis and susceptibility to asthma. Lancet. 1998 Jun 27;351(9120):1911-3. doi: 10.1016/s0140-6736(97)11419-2.

    PMID: 9654257RESULT

  • Dahl M, Nordestgaard BG, Lange P, Tybjaerg-Hansen A. Fifteen-year follow-up of pulmonary function in individuals heterozygous for the cystic fibrosis phenylalanine-508 deletion. J Allergy Clin Immunol. 2001 May;107(5):818-23. doi: 10.1067/mai.2001.114117.

    PMID: 11344348RESULT

Biospecimen

Retention: SAMPLES WITH DNA

From peripheral blood samples, the DNA extraction following the protocol saline method. From the DNA samples obtained CFTR gene analysis to detect genetic variants by sequencing or mass Next Generation Sequencing (NGS) in Miseq team Illumina platform (available in the Hospital de la Santa Creu i Sant be held Pau).

MeSH Terms

Conditions

AsthmaCystic Fibrosis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Astrid Crespo

    Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

September 23, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

October 19, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)