To evaluate efficacy and safety of Respiforb in patients with partly controlled asthma
- Conditions
- Health Condition 1: J40-J47- Chronic lower respiratory diseasesHealth Condition 2: L00- Staphylococcal scalded skin syndrome
- Registration Number
- CTRI/2018/09/015862
- Lead Sponsor
- PSK Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method