To evaluate efficacy and safety of Respiforb in patients with partly controlled asthma

Suspended

• Conditions: Chronic lower respiratory diseases, (2) ICD-10 Condition: L00||Staphylococcal scalded skin syndrome,

• Registration Number: CTRI/2018/09/015862
• Lead Sponsor: PSK Pharma LLC

Brief Summary

The planned study is an open-label, multicenter, randomized, comparative study to evaluate efficacy and safety of Respiforb®, inhalation powder, pre-dispensed 320+9 μg/dose (Sava Healthcare Limited, India) and Symbicort® Turbuhaler®, inhalation powder, pre-dispensed 320+9 μg/dose (AstraZeneca AB, Sweden) in patients with partly controlled asthma.

Total duration of the study for each patient will not exceed 102 days

The 1st group of patients will receive Respiforb® – 1 inhalation (320+9 mcg/dose) twice daily for not more than 88 days (up to Visit 4 inclusive).

The 2nd group of patients will receive Symbicort® Turbuhaler® – 1 inhalation (320+9 mcg/dose) twice daily for not more than 88 days (up to Visit 4 inclusive).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-10
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Availability of a signed copy of the Informed Consent Form of the Patient Information Leaflet.
• Male and female patients 18 to 70 years of age (inclusive) at the moment of signing the Informed Consent Forms (ICF).
• Diagnosis of persistent asthma established according to the GINA guidelines (2017) not less than 6 months prior to the screening visit.
• Asthma that is inadequately controlled by inhaled corticosteroids (ICS) inhaled corticosteroids and short-acting beta-agonists (SABA) as on-demand therapy.
• Need to use bronchodilatory therapy with a combination of ICS and long-acting beta agonists (LABA).
• ACQ-5 score ≥0.75 and <1.5.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in FEV1	At Visits 1 and 4

Secondary Outcome Measures

Name	Time	Method
FEV1 changes	assessed 2 hours after inhalation of the test drug/reference drug.
PEF changes	by Visits 2, 3, and 4.
ACQ-5 score	changes over time.
SF-36 (quality of life questionnaire) score	changes over time.
Percentage of patients achieving asthma control	by Visit 4.
Weekly average daily SABA requirement (salbutamol)	at Week 1, 4, 8, and 12.
Percentage of patients who developed exacerbation	by Visits 2, 3, and 4.

Trial Locations

Locations (2)

AIMS Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Rajpal Hospital; 🇮🇳 Thane, MAHARASHTRA, India

AIMS Hospital

🇮🇳Thane, MAHARASHTRA, India

Dr Deepak Varade

Principal investigator

9870409142

deepak.varade@gmail.com