A clinical trial to study the effects of newer anti histamines in patients with bronchial asthma

Effect of Second Generation Antihistamines on Pulmonary Function in Bronchial Asthma: A Double Blind Randomized Controlled Clinical Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000082

Enrollment

160

Registered

2008-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: cetirizine, levocetirizine, loratadine, desloratadine, fexofenadine: 10mg OD for 1 month, 10 mg OD for 1 month, 10mg OD for 1 month, 10mg OD for one month, 180 mg OD for 0ne month Contr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients with moderate to severe bronchial asthma on inhalational corticosteroids and &#946;2 agonists 2. Presenting with symptoms of allergic rhinitis 3. Age 18 - 60 years 4. Either gender

Exclusion criteria

Exclusion criteria: 1. Patients experiencing an acute attack of asthma at the time of recruitment 2. Patients on methylxanthines 3. Patients on oral corticosteroids 4. Other concomitant medical conditions requiring regular treatment, i.e.,hypertension, diabetes mellitus, thyroid disorders, psychiatric disorders 5. Patients who are very sick either due to bronchial asthma or due to any other cause

Design outcomes

Primary

Measure	Time frame
1. Forced Expiratory Volume in one second (FEV1) 2. Forced vital capacity (FVC) 3. Oxygen saturation Timepoint: At 2/4 hours post dose on day 1, at end of 2 weeks and at end of 4 weeks	—

Secondary

Measure	Time frame
1.Psychometrics and cognitive function â?? a battery of eleven tests i.e., finger tapping test, simple reaction test, choice reaction test, choice discrimination test, digit picture substitution test, digit symbol substitution test, digit letter substitution test, card sorting test, digit vigilance task, immediate picture recall test and numeric working memory test. 2. Adverse drug reactions as reported by patients 3. Subjective assessment of wellbeing â??Asthma Quality of Life Questionnaire 4. No. of exacerbations seen during the period under studyTimepoint: Psychomotor testing to be done at baseline, end of 2 hours on Day one post dose, at end of two weeks and at end of four weeks. Asthma Quality of Life Questionairre will be evaluated at start of study and at end of four weeks.	—

Measure

Time frame

1.Psychometrics and cognitive function â?? a battery of eleven tests i.e., finger tapping test, simple reaction test, choice reaction test, choice discrimination test, digit picture substitution test, digit symbol substitution test, digit letter substitution test, card sorting test, digit vigilance task, immediate picture recall test and numeric working memory test. 2. Adverse drug reactions as reported by patients 3. Subjective assessment of wellbeing â??Asthma Quality of Life Questionnaire 4. No. of exacerbations seen during the period under studyTimepoint: Psychomotor testing to be done at baseline, end of 2 hours on Day one post dose, at end of two weeks and at end of four weeks. Asthma Quality of Life Questionairre will be evaluated at start of study and at end of four weeks.

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Countries

India

Contacts

Public ContactDr. Shahid Akhtar Md

Junior Resident, JIPMER

satyamveshi@gmail.com(0413) 2272380 extn 3302

Outcome results