Effect of inhaled Cromolyn on persistent asthma

Phase 2

Conditions: Asthma.
Mild Persistent Asthma, Status asthmaticus
J45.32

Registration Number: IRCT201108042695N3

Lead Sponsor: Mashhad Branch-Islamic Azad University

Brief Summary: Objectives: The objective of this study was to determine the effect of cromolyn on clinical findings and neutrophilic inflammation of resistant cough variant of asthma.<br /> Material and methods: Subjects suffering from cough variant of asthma with a normal physical exam and spirometry were treated by inhaled corticosteroid, antileukotriene, antibiotics, and proton pomp inhibitors with the stepwise approach recommended by the GINA guidelines. Seventy subjects resistant to all of these treatments were enrolled in this randomized double blind clinical trial. After randomization eligible subjects received cromolyn or a placebo MDI inhaler that was completely similar in appearance to the cromolyn inhaler. Primary outcomes included a cough and ACT (Asthma control test) score. Secondary outcomes (variables) included other clinical findings, spirometry, sputum cytology including inflammatory cell, and FENO (Fractional Exhaled Nitric Oxide).<br /> Results: Coughing significantly decreased with cromolyn therapy (12% after the trial), which was significantly lower than the placebo group (75%). Similarly, other clinical findings including dyspnea, sputum and nocturnal symptoms also improved. The ACT score improved in the cromolyn group significantly to near normal (23.53±2.25). FENO significantly decreased with the cromolyn treatment (14±9.31 PPM compared to 28.88±27.39 PPM before treatment), but spirometry parameters did not change. Neutrophil as the most frequent sputum inflammatory cell significantly decreased in the cromolyn group (from 44±24.2% to 34.08±16.7% after the trial), but this cell increased in the placebo group (from 39.67±26.47% to 56.71±27.22%).<br /> Conclusion: Cromolyn improved the clinical findings of cough variant of asthma resistant to ICS and antileukotrienes and was able to suppress neutrophilic inflammation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 62

Inclusion Criteria

cough with an intermittent course and history of airway hyper responsiveness; FEV1(Forced Expiratory volume in 1 second) more than 80% (mild asthma); No beneficial effect of inhaled Corticosteroid anti leukotriene during previous treatment.
Exclusion criteria: Moderate or severe asthma; FEV1 (Forced Expiratory volume in 1 second) lees than 80%; Asthma with wheezing; Respiratory infection; Treatment with systemic Corticosteroid; Other Obstructive lung disease; Rhinosinositis; Gastro-esophageal Reflux; Vocal Cord Dysfunction; Reactive airway dysfunction syndrome.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chenge of FENO (Fractional Exhaled Nitric Oxide). Timepoint: Before treatment and 40 days after treatment. Method of measurement: Chemilumine scence instrument, No Breath, Bed font company, England.;Chenge of FEV1 (Forced Expiratory volume in 1 second). Timepoint: Before treatment and 40 days after treatment. Method of measurement: Spirometry super Spiro, Micro medical company, England.;Chenge of Sputum Cytology. Timepoint: Before treatment and 40 days after treatment. Method of measurement: Sputum Cytology for frequency of inflammatory cell (Eosinophil, Neutrophil, Macrophage and Lymphocyte) defined by percentage calculated into 200 cell in each high power field Microscopic in magnification 40x in Sputum.

Secondary Outcome Measures

Name	Time	Method
Chenge of IL-8. Timepoint: One year later. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Chenge of INF- GAMMA. Timepoint: One year later. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Chenge of IL-17. Timepoint: One year later. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Chenge of TLR-2. Timepoint: One year later. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).