]>
IRCT138804222118N1 IRCT 2011-07-10 RESEARCH DEPEUTY, SHAHED UNIVERSITY Effects of cromolyn sodium on lung function in asthmatic patients Effects of sodium cromoglycate on lung function tests in asthmitc subejects without exposure to any bronchoconstrictor trigger 2011-06-02 anticipated 120 Complete https://irct.ir/trial/1745 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A bronchial asthma. Intervention 1: 1. cromolyn 20 group: Patient must inhale powder content of a capsule of cromolyn sodium (20 mg) by spinhaler through mouth. Intervention 2: 2. cromolyn 40 group: Patient must inhale 40mg powder of cromolyn sodium by spinhaler through mouth. Intervention 3: 3. placebo group:Patient must inhale from a hollow and cleaned (dose not contain any drug) capsule of cromolyn sodium by spinhaler through mouth. www.ijpr.ir Sodium cromoglycate (cromolyn sodium, cromolyn, Intal) is a mast cell stabilizing agent which is used in bronchial asthma. Cromolyn is ineffective in reversing acute asthmatic bronchospasm, and it has a prophylactic role in asthma. However, pretreatment with cromolyn blocks the bronchoconstriction caused by factors such as allergen inhalation, exercise and sulfur dioxide; so, it has an acute protective role. This acute effect of cromolyn may be associated with changes in lung function parameters. Therefore, the aim of this work is to determine the extent of immediate changes in baseline lung function test, following inhalation of cromolyn sodium in adult asthmatics in stable condition, at rest. Forty volunteers (33 women and 7 men) with moderate persistent, or severe persistent asthma (GINA classification) were randomly assigned to receive cromolyn-20 mg, cromolyn-40 mg or cromolyn-placebo, by spinhaler. Then, after inhalation of drug or placebo, lung function was performed at 15, 30 and 60 min, and percent of improvement in each lung parameter such as forced expiratory flow volume in one second (FEV1), forced vital capacity (FVC) and maximal expiratory flow 75 (MEF75) was obtained at each time point. <br /> Our results showed that for most parameters, and almost at all times; both frequency of positive changes and % improvement were more for patients in cromolyn-20 than for other groups. For example, at 15 min, the % improvement in FEV1 was 3.35 ± 1.5, for cromolyn-20 vs. 0.98 ± 1.4 and (- 0.68) ± 1.2 for cromolyn-placebo and cromolyn-40 mg groups, respectively. However, differences in the means of % improvement were not statistically significant between three groups. Moreover, unlike other groups, a post-bronchodilatoer response [that is % improvement in FEV1≥ 12% (American Thoracic Society)] occurred in a few patients in cromolyn-20 group, at 15 min of use. According to these findings, it is concluded that at stable asthmatic condition, and in the absence of any bronchial challenge, sodium cromoglycate probably has no significant effect on baseline lung function parameters, in adults with moderate or severe persistent asthma. <br />
public DR TAJEMAH MOMBEINI
DEPARTMENT OF PHARMACOLOGY, SCHOOL OF MEDICINE, NO 29, ABDOLLAH-ZADEH ST, KESHAVARZ BLVD, TEHRAN
TEHRAN Iran (Islamic Republic of) +98 21 8896 4792 t.mombeini@gmail.com SCHOOL OF MEDICINE, SHAHED UNIVERSITY scientific ِDR TAJEMAH MOMBEINI
DEPARTMENT OF PHARMACOLOGY, SCHOOL OF MEDICINE, NO 29, ABDOLLAH-ZADEH ST, KESHAVARZ BLVD, TEHRAN
TEHRAN Iran (Islamic Republic of) +98 21 8896 4792 t.mombeini@gmail.com, mombeini@shahed.ac.ir SCHOOL OF MEDICINE, SHAHED UNIVERSITY Iran (Islamic Republic of) Inclusion critreia: subjects with documented diagnosis of asthma and reversible airflow obstruction; FEV1<80% of predicted value;in a stable condition with regard to asthma symptoms Exclusion criteria: acute attack of asthma; chronic disease such as heart disease; pateints with respiratory infection in last month; smoking 27 years 57 years Both j45 Predominantly allergic asthma Treatment - Drugs Treatment - Drugs Treatment - Drugs 1. cromolyn 20 group: Patient must inhale powder content of a capsule of cromolyn sodium (20 mg) by spinhaler through mouth. 2. cromolyn 40 group: Patient must inhale 40mg powder of cromolyn sodium by spinhaler through mouth. 3. placebo group:Patient must inhale from a hollow and cleaned (dose not contain any drug) capsule of cromolyn sodium by spinhaler through mouth. FEV1. Timepoint: 15 min, 30 min, 60min after inhalation. Method of measurement: Spirometry test. FVC. Timepoint: 15min, 30min, 60min after inhalation. Method of measurement: spirometry test. PEF. Timepoint: 15 min, 30 min, 60min after inhalation. Method of measurement: Spirometry test. MEF25%. Timepoint: 15 min, 30 min, 60min after inhalation. Method of measurement: Spirometry test. MEF50%. Timepoint: 15 min, 30 min, 60min after inhalation. Method of measurement: Spirometry test. MEF75%. Timepoint: 15 min, 30 min, 60min after inhalation. Method of measurement: Spirometry test. Adverse effects after inhalation of drug or placebo. Timepoint: each 15 min after inhalation, until 2 hours. Method of measurement: observation. RESEARCH DEPEUTY, SHAHED UNIVERSITY Approved 2011-06-01 ETHIC COMMITTEE of SHAHED UNIVERSITY RESEARCH DEPEUTY, SHAHED UNIVERSITY, AGAINST IMAM-KHOMEINI HARAM, FIRST OF TEHRAN-GHOAM HIGHWAY, TEHRAN, IRAN TEHRAN Iran (Islamic Republic of)