Health Condition 1: null- Mild and moderate persistent bronchial asthma
Conditions
Interventions
Intervention1: Salmeterol plus Fluticasone Propionate
Test Drug Fluzon 250 HFA
International Non-Proprietary Name Fluticasone Propionate
: Dose 1 inhalation 2 times a day (a total dose of Fluticaso
Sponsors
Rus Biopharm LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female patients, aged from 18 to 70 years; 2 Written informed consent, obtained from the patient before any procedure related to the study; 3 Diagnosis of persistent asthma, established according to the GINA guidelines, version 2011, at least 6 months prior to the screening visit; 4 Partially controlled bronchial asthma (GINA 2011) 5 Patients, who demonstrates the use of iGCS in the form of inhalations. 6 daytime symptoms of BA > 1 times a day 7 night symptoms of BA > 1 times per week 8. forced expiratory volumes per 1 sec (FEV1) and peak expiratory flowrates (PEFR) in the range of 60 to 80% of age norms; 9 reversibility of obstruction in tests with short-acting β2agonists >= 12% and >= 200 ml compared to baseline, through 15 to30 minutes after the administration of 400 µg salbutamol; 10 daily bronchial lability > 30% 11 Patients should have used stable background therapy of bronchial asthma with inhaled iGCS (except for fluticasone, cromones, or leukotriene-receptor antagonists) for at least 4 weeks before the screening visit. The average stable dose of inhaled glucocorticosteroids is defined as the dose of budesonide or equivalent product from >= 500 μg to 12 Daily requirement in short-acting β8agonists of not more than 2 inhalations per day for 3 consecutive days, 3 to 7 times per week During the study combined preparations, containing M cholinoblockers and short-acting β2-agonists (e.g., berodual), must be replaced with short-acting β2-agonists 13 Patients with total scores under the Asthma Control Questionnaire (ACQ) of more than 0.75 14 Willingness to cooperate when performing study procedures. 15Negative pregnancy test For women of child-bearing potential urine test for pregnancy will be performed at screening
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women or all women physiologically capable of becoming pregnant, except those that fall under the following definition of postmenopausal women: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with the documented serum FSH level > 40 mIU/ml, or using one or more of the following acceptable methods of contraception; surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implant, patch, oral), double barrier methods (any dual combination of the following methods: intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). 2. Significant seasonal variation of bronchial asthma or bronchial asthma that occurs only during periodic exposure to allergens or chemical sensitizers; 3. History of bronchial asthma with almost fatal outcome (e.g., unstable bronchial asthma, hospitalizations due to asthma exacerbation in the intensive therapy unit with the application of intubation); 4. Diagnosis of COPD, established under the current version of GOLD guidelines, version 2009; 5. Exacerbation of bronchial asthma within 4 weeks prior to the screening visit, requiring the use of system glucocorticosteroids and hospitalizations (more than 24-hour hospital stay); 6. Frequent exacerbations of asthma: over 4 exacerbations 52 weeks before inclusion in the study; 7. Frequent night awakenings: more than 3 times a week; 8. Large requirement in short-acting β2-agonists (SABA) of not more than 2 inhalations per day for 2 consecutive days; 9. The use of fluticasone or fixed combination of iGCS and long- acting β2-agonists (LABA) for the treatment of bronchial asthma; 10. Lower respiratory tract infection within 1 month before screening visit; 11. History of mucoviscidosis, bronchiectasis or alpha-1 antitrypsin deficiency; 12. Diagnosis of restrictive pulmonary process; 13. Glaucoma, cataract; 14. Intolerance or contraindications to the treatment with ï?¢2-agonists and/or inhalation corticosteroids or allergy to any component of the investigated pharmacotherapy; 15. The presence of significant medical history and/or treatment of cardiac, renal, neurologic, hepatic, endocrine diseases or the presence of any abnormalities in laboratory indicators that can serve as an indicators of a significant disease that may affect patientâ??s safety, compliance, or assessment of the study, require the use of banned drugs, according to the investigator. 16. Cancer or a history of cancer within 5 years; 17. Smoking patients or ex-smokers, who smoked more than 10 pack-years and quitted smoking less than 1 year prior to inclusion in the study. (Pack-year: number of cigarettes, smoked per day, multiplied by the number of years of smoking/20); 18. Conditions, requiring the use of systemic glucocorticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average value of asthma control level according to the questionnaire ACQ Time points 12 weeks Relative change in forced expiratory volume per one second (FEV1) from baseline Time points 12 weeks Timepoint: Time points 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with the achieved asthma control level of less than 0,75 points according to the asthma control test (ACT questionnaire) in two groups at weeks 4, 8 and 12 of the study Timepoint: Time-points: 4 week, 8 week, 12 week ;The incidence of increasing doses of SP/RP up to 750 and 1000 mcg/day Timepoint: Time-points: 12 weeks;The number of exacerbation/frequency of calls for emergency help due to the main disease during the observation period in two groups Timepoint: Time-points: 12 weeks;Average value of asthma control level according to questionnaires ACT and AQLQ S Timepoint: Time points: 4 week, 8 week, 12 week | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Mangesh Khadakban
Nexus Clinical Research India Ltd
Outcome results
None listed