Asthma With Hypersecretion-associated Gene for Cystic Fibrosis

Asthma Clinical Trial

— CF-asthma  

Official title:

Asthma With Hypersecretion-associated Gene for Cystic Fibrosis Clinical, Inflammatory and Genetics Characterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558127
• Other study ID #: IIBSP-CFT-2014-68
• Secondary ID: ESR-15-10784
• Status: Completed
• Phase: N/A
• First received: June 15, 2015
• Last updated: October 18, 2016
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Description:

Primary objective:

Determine the presence of genetic variants (mutations and / or polymorphisms) of the CFTR gene in patients with asthma with or without bronchial mucus hypersecretion.

Secondary objectives:

To identify genetic variants (mutations and / or polymorphisms) of the most common CFTR gene in the asthmatic population. -To define the inflammatory phenotype of asthma with bronchial mucus hypersecretion. -To compare the severity, control, quality of life and frequency of exacerbations of asthma patients with or without bronchial mucus hypersecretion

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria: Asthmatic patients aged between 18 and 80 years.They have not a respiratory infection in the last month.

Criteria for exclusion: Presence of other lung disease, Sequelae of tuberculosis, Bronchiectasis (large, secondary to a different asthma respiratory disease), Cystic fibrosis, Residual pleural disease, Interstitial diseases, Severe comorbidity, Patients with oral corticosteroids or other immunomodulators by causes other than asthma.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma
• Cystic Fibrosis
• Fibrosis

Intervention

Genetic:
• Asthma patients
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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. Erratum in: Lancet 1998 Oct 10;352(9135):1230. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of asthmatic patients CF carriers		12 months	No
Secondary	Noncarriers number of asthmatics		12 months	No