Health Condition 1: J40-J47- Chronic lower respiratory diseases Health Condition 2: L00- Staphylococcal scalded skin syndrome
Conditions
Interventions
Intervention1: Respiforb
: Inhalation powder, pre-dispensed
Dose regimen- One inhalation (320+9 μg/dose) twice daily
Route of administration is oral
Frequency twice daily for 80 days
Control Interv
Sponsors
PSK Pharma LLC
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Availability of a signed copy of the Informed Consent Form of the Patient Information Leaflet. 2. Male and female patients 18 to 70 years of age (inclusive) at the moment of signing the Informed Consent Forms (ICF). 3. Diagnosis of persistent asthma established according to the GINA guidelines (2017) not less than 6 months prior to the screening visit. 4. Asthma that is inadequately controlled by inhaled corticosteroids (ICS) inhaled corticosteroids and short-acting beta-agonists (SABA) as on-demand therapy. 5. Need to use bronchodilatory therapy with a combination of ICS and long-acting beta agonists (LABA). 6. ACQ-5 score >=0.75 and <1.5
Exclusion criteria
Exclusion criteria: 1. Patients who need the selection of initial maintenance therapy for asthma. 2. Contraindications for use of ICS, hypersensitivity to budesonide, formoterol, salbutamol, inhaled lactose or to any other component of the study drugs. 3. Lactose intolerance, lactase deficiency, or glucose - galactose malabsorption. 4. A diagnosis of chronic obstructive pulmonary disease (COPD) established according to the 2017 version of the GOLD guidelines. 5. Excessive requirement of SABA 6. Use of oral or parenteral corticosteroids within 2 months prior to the screening visit (3 months for extended-release parenteral ICS). 7. The use of immunosuppressive agents (e.g., cyclosporine, methotrexate, tumor necrosis factor (TNF) inhibitors or anti-TNF-antibodies, gold salts, azathioprine) within 4 weeks prior to the screening visit. 8. Conditions that require the use of systemic therapy with corticosteroids at the time of the screening visit. 9. Unexpected progressive deterioration of asthma symptom control. 10. A history of a nearly fatal asthma attack (e.g., unstable asthma, hospitalization due to asthma exacerbation to ICU with the use of intubation). 11. Pulmonary tuberculosis (active or inactive form). 12. Fungal, viral, or bacterial respiratory tract infections, or systemic viral infection, Herpes simplex-related eye disease at the moment of the screening visit. 13. Lower respiratory tract infection within 1 month prior to the screening visit. 14. Cystic fibrosis, bronchiectasis, pneumoconiosis. 15. Restrictive ventilatory defects. 16. Uncontrolled hypokalemia, hypocalcaemia. 17. Thyrotoxicosis. 18. Osteoporosis. 19. Glaucoma, cataract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FEV1Timepoint: At Visits 1 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| ACQ-5 scoreTimepoint: changes over time.;FEV1 changesTimepoint: assessed 2 hours after inhalation of the test drug/reference drug.;PEF changesTimepoint: by Visits 2, 3, and 4.;Percentage of patients achieving asthma controlTimepoint: by Visit 4.;Percentage of patients who developed exacerbationTimepoint: by Visits 2, 3, and 4.;SF-36 (quality of life questionnaire) scoreTimepoint: changes over time.;Weekly average daily SABA requirement (salbutamol)Timepoint: at Week 1, 4, 8, and 12. | — |
Countries
India, Russian Federation
Contacts
Public ContactDr M Waghmare
Mudra Clincare
Outcome results
None listed