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Completed

NCT Number: NCT02558127

Asthma With Hypersecretion-associated Gene for Cystic Fibrosis

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.

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Key information

Conditions

Asthma Bronchial Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infant, Newborn, Diseases Lung Diseases Lung Diseases, Obstructive Pancreatic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Barcelona, 08041, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Asthma patients

Genetic

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.

Primary outcomes

  1. Number of asthmatic patients CF carriers

    Time frame: 12 months

Secondary outcomes

  1. Noncarriers number of asthmatics

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: CF-asthma

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2015
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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