A Phase IV, open-label, prospective, randomised clinical trial to evaluate the usefulness of measuring nitric oxide in exhaled air in the therapeutic management of adult patients with mild asthma

Phase 1

• Conditions: Treatment in non-smoking adult patients with mild persistent atopic bronchial asthma; MedDRA version: 14.1Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-000372-42-ES
• Lead Sponsor: Fundació per la Recerca i la Docència Sant Joan de Déu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who have previously given their informed consent to participate in the study will be included. a) Aged between 18 and 65 years. b) Initial diagnosis of mild persistent bronchial asthma according to the definition of the latest GEMA guidelines, well controlled with no exacerbations in the previous 3 months, ACT>20, normal spirometry and negative bronchodilator test. Patients already known and managed in the Pneumology Department of Parc Sanitari Sant Joan de Déu will be included. c) Atopy, defined as: elevated total IgE and/or allergy tests (skin prick or RAST testing) positive for respiratory pneumoallergens and/or peripheral eosinophilia.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

a) Patients who do not fulfil the criteria defined in the GEMA guidelines for uncontrolled mild persistent bronchial asthma. b) Patients with an obstructive pattern on spirometry explained by another disease: COLD, sequelae of tuberculosis, bronchiolitis, etc. c) Patients who are clinically unstable at the time of inclusion or who have worsened in the 3 months prior to study inclusion. d) Patients who cannot correctly take treatment via the inhaled route. e) Patients with muscular disorders (myasthenia gravis, Parkinson’s). f) Patients who are smokers or ex-smokers. g) Patients requiring essential treatment which may produce bronchoconstriction of the airways (e.g. beta-blockers). h) Women who are pregnant or nursing. j) Patients included in any other research protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified