Bioequivalence With Clinical Endpoint Study of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma

Inclusion Criteria:

1. Male or female subjects (≥12 years of age) of non-childbearing or of childbearingpotential committed to consistent and correct use of an acceptable method of birthcontrol.
2. Patients diagnosed with asthma, as defined by the National Asthma Education andPrevention Program (NAEPP), at least 12 weeks prior to screening.
3. Pre-bronchodilator FEV1 of ≥40% and ≤85% of the predicted value (for age ≥18 years),or ≥65% and ≤90% predicted normal value (for ages 12 to 17 years) during the screeningvisit and on the first day of treatment.
4. Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipetobacco) within the past year, and had ≤ 10 pack-years of historical use.
5. ≥12% and 200 mL reversibility of FEV1 within 30 minutes following 400 mcg salbutamol (4 puffs) inhalation (pMDI). This may be demonstrated at the Screening Visit or thistest may be repeated on a different day if the patient fails the first attempt anytimein the period leading up to Visit 2 (randomization); If reversibility is notdemonstrated up to Visit 2 then patients may be permitted to enter the study withhistorical evidence of reversibility that was performed within 2 years prior to Visit 1 and patients should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to enrolment.
6. Patients who are able to discontinue their asthma medications (inhaled corticosteroidsand long-acting β agonists) during the run-in period and for remainder of the study,according to investigator's judgement.
7. Patients who are able to replace current short-acting β agonists (SABAs) withsalbutamol inhaler for use as needed for the duration of the study (subjects should beable to withhold all inhaled SABAs for at least 6 hours prior to lung functionassessments on study visits).
8. Patients who are able to continue treatment with theophylline or montelukast without asignificant adjustment of dosage, formulation, dosing interval for the duration of thestudy, and judged able by the investigator to withhold them for the specified minimumtime intervals prior to each patient visit: 1) montelukast 36 hours 2) short-actingforms of theophylline 12 hours, 3) twice-a-day controlled-release forms oftheophylline 24 hours, 4) once-a-day controlled-release forms of theophylline 36hours.
9. Patients who are able to understand the requirements of the clinical trial and toagree to return for the required follow-up visits.
10. Willing to provide voluntary written informed consent and data protection declaration (and in the case of a minor their parent/guardian was able to give) before anyclinical trial related procedure is performed.

Exclusion Criteria:

1. Life-threatening asthma, defined as a history of asthma episode(s) requiringintubation, and/or associated with hypercapnia; respiratory arrest or hypoxicseizures, asthma related syncopal episode(s), or hospitalizations within the past yearto the screening or during the run-in period.
2. Evidence or history of clinically significant disease or abnormality includingcongestive heart failure, uncontrolled hypertension, uncontrolled coronary arterydisease, myocardial infarction, or cardiac dysrhythmia.
3. Historical or current evidence of significant hematologic, hepatic, neurologic,psychiatric, renal, or other diseases that in the opinion of the investigator, wouldput the patient at risk through study participation, or would affect the studyanalyses if the disease exacerbated during the study.
4. Hypersensitivity to any sympathomimetic drug (e.g., salmeterol/albuterol) or to anyinhaled, intranasal, or systemic corticosteroid therapy.
5. History of hypersensitivity to lactose
6. Medication(s) with the potential to affect the course of asthma or to interact withsympathomimetic amines, e.g.: β-blockers, oral decongestants, benzodiazepines,digitalis, phenothiazines, polycyclic antidepressants, monoamine oxidase inhibitors.
7. symptoms or signs of viral or bacterial, upper or lower respiratory tract infection orsinus or middle ear infection within 4 weeks prior to the screening visit or duringthe run-in period.
8. Asthma exacerbation (i.e. acute or sub-acute worsening in symptoms and lung functionfrom the patient's usual status) within 6 weeks prior to the screening visit or duringthe run-in period
9. Use of oral or parenteral corticosteroids within 4 weeks prior to Screening visit (Visit 1)
10. Factors (e.g., infirmity, disability or geographic location) that the investigatorfelt would likely limit the patient's compliance with the study protocol or scheduledclinic visits.
11. Female Subjects who are pregnant or breastfeeding.
12. Women of child-bearing age that are not surgically incapable of pregnancy and are notwilling to use an acceptable method of birth control.
13. Current participation or not yet completed period of at least 30 days since endingother investigational device or drug trial(s).
14. Unwillingness or inability to comply with the clinical trial procedures;
15. Unwillingness to consent to storage, saving and transmission of pseudonymous medicaldata for clinical trial reasons;
16. Who are legally incapacitated;
17. Who are legally detained in an official institute.