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Effect of inhaled Cromolyn on persistent asthma

Effect of inhaled Cromolyn on cough of mild persistent asthma in resistant patients to inhaled Corticosteroid and antileukotriene, A double blind randomized clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201108042695N3
Enrollment
62
Registered
2014-04-13
Start date
2012-09-28
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma. Mild Persistent Asthma, Status asthmaticus

Interventions

Intervention 1: Steps before starting the study: Asthmatic subjects referred with cough and history of recurrence with or without reactive airway hyper responsiveness and without wheezing will be trea
Diagnosis
Treatment - Drugs
Steps before starting the study: Asthmatic subjects referred with cough and history of recurrence with or without reactive airway hyper responsiveness and without wheezing will be treated with one puf
After pretest evaluations, patients will be randomly divided in two groups and will be received cromolyn spray or placebo for 40 days four time daily two puff with spacer. Cromolyn and placebo have si

Sponsors

Mashhad Branch-Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Mirsadraee

Mashhad Branch-Islamic Azad University

majidmirsadraee@mshdiau.ac.ir+98 51 1841 6694

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026