A clinical trial to study the effects of newer anti histamines in patients with bronchial asthma
Phase 4
- Registration Number
- CTRI/2008/091/000082
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. Adult patients with moderate to severe bronchial
asthma on inhalational corticosteroids and β2 agonists
2. Presenting with symptoms of allergic rhinitis
3. Age 18 - 60 years
4. Either gender
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Forced Expiratory Volume in one second (FEV1)<br>2. Forced vital capacity (FVC)<br>3. Oxygen saturation<br>Timepoint: At 2/4 hours post dose on day 1, at end of 2 weeks and at end of 4 weeks
- Secondary Outcome Measures
Name Time Method 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.