A clinical trial to study and compare the effects two dry powder inhaler devices,test and reference, containing salmeterol 25mcg and fluticasone propionate 250mcg with salmeterol 50mcg and fluticasone propionate 500mcg in patients with asthma.
- Conditions
- Health Condition 1: J459- Other and unspecified asthma
- Registration Number
- CTRI/2008/091/000302
- Lead Sponsor
- Sun Pharma Advanced Research Company Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 113
•Men and women age 18-60 years inclusive.
•Women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or log acting injected contraceptives] for atleast 2 months prior to study entry. Or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject), with a negative urine pregnancy test.
•BMI within 18.5 â?? 30.0 kg/m2 inclusive.
•Received pharmacotherapy for asthma for the preceding 6 months: either inhaled corticosteroids for the last 3 months preceding screening or inhaled long-acting β2 agonists for at least 1 week prior to screening, or on combination of both the drugs with a washout of 2 weeks prior to taking study medication.
•Reversible bronchial obstruction (Bronchial obstruction is defined as reversible when inhalation of 200 mcg (two actuations of 100 mcg) of salbutamol from a MDI causes the FEV1 value to increase by at least 12% or 200 ml within 15 minutes)
•Screening visit FEV1 is 40- 80% of the predicted normal value
•Withholding the following medication for the specified time prior to screening and for the duration of the study:
•Oral corticosteroids•1 month
•Parenteral corticosteroids•1 month
•Inhaled anticholinergics•24 hours
•Inhaled cromolyn or nedocromil sodium•1 month
•Oral short-acting β2 agonists•12 hours
•Oral long-acting β2 agonists•24 hours
•Inhaled long-acting β2 agonists•24 hours
•Anti-histamines like Cetirizine, Terfenadine, Fexofenadine,
•Hydroxyzine, Ebastine, Azatadine•72 hours
•Oral and Parenteral Macrolide antibiotics•30 days
•Subject Inclusion Criteria at Visit 2
o8.1 For subjects who were using inhaled corticosteroids at screening; not more than 12 puffs per day of salbutamol for more than 3 days of their last 7 days during 2-week run-in.
oFor subjects who were using inhaled long-acting β2 agonists at screening; not more than 6 puffs per day of salbutamol for more than 3 days of their last 7 days during 2-week run-in.
oSubjects who awakened due to asthma; not more than 3 days of last 7 nights during 2-week run-in.
oFEV1 is within +15% of the screening visit value and within 40- 80% of the predicted normal at Visit 2 (randomization).
*History or presence of significant:
Allergy or Significant history of hypersensitivity or idiosyncratic reactions to fluticasone and salmeterol or any related compounds etc.; Severe exacerbation of asthma that required hospitalization in last 2 months; Occupational asthma; Change of asthma medication during the preceding 4 weeks; Associated COPD; Active respiratory tract infection; Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year; Clinically significant illness within 4 weeks before the start of the study; Clinically significant abnormal ECG or chest x-ray; Inability to use DPI device correctly.*Current smokers or subjects with a ≥ 10 pack year history.*Participation in another clinical trial within the preceding 90 days of study starts.*Currently taking β-blockers, oral decongestants, benzodiazepines, digitalis, phenothiazines, antidepressants, MAO inhibitors.*Use of medications like ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin that significantly interact with cortcosteroids metabolism within 6 weeks of enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average change from baseline to end of study (4-week treatment period) in morning PEFR.Timepoint: Prospective
- Secondary Outcome Measures
Name Time Method Average change from baseline to end of study (4-week treatment period) in evening PEFR;Timepoint: Prospective;Average change from baseline to end of study (4-week treatment period) for salbutamol use, nighttime awakenings and symptom scores;Timepoint: Propective;Average change from baseline to end of study (4-week treatment period) in pre-dose FEV1;Timepoint: Prospective;Subject?s Global Impression of change and Principal Investigator rated Clinical Global Impression (CGI) of change based on symptom relief.Timepoint: Prospective