Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Dry powder inhaler containing Salmeterol 25 mcg /Fluticasone Propionate 250 mcg: twice daily for 4 weeks
Control Intervention1: Dry Powder inhaler ® containing Salmeterol 50 mcg/ Fluti
Sponsors
Sun Pharma Advanced Research Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • 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 o 8.1 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. o For 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. o Subjects who awakened due to asthma; not more than 3 days of last 7 nights during 2-week run-in. o FEV1 is within +15% of the screening visit value and within 40- 80% of the predicted normal at Visit 2 (randomization).
Exclusion criteria
Exclusion criteria: *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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average change from baseline to end of study (4-week treatment period) in morning PEFR.Timepoint: Prospective | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar
Outcome results
None listed