A Clinical study to compare the effictiveness and safety of Forb 100 HFA aerosol for inhalation and Foradil Combi set of capsules with inhalation powder in patients with Asthma.

Phase 3

Completed

• Conditions: Chronic lower respiratory diseases,

• Registration Number: CTRI/2017/05/008531
• Lead Sponsor: RUS Biopharm LLC

Brief Summary

**An Open label, Multicenter, Randomized Comparative clinical study to evaluate the efficacy and safety of drugs Forb 100 HFA ( Generic name : Budesonide + Formoterol ) metered dose aerosol for inhalation and Foradil combi set of capsules with inhalation powder in patients with Partially controlled Asthma . Duration of the Study for the patients will not exceed 109 days. Objectives of the study :-  To assess the efficacy , Safety and effect of  the product on the quality of life with  Forb 100 HFA ,metered dose aerosol for inhalation compared with Foradil combi set of capsules with inhalation powder in patients with Partially controlled Asthma. In this study   total number of 140 subject will be randomized , 24 of which in Russia and 116 in India .**

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-02
• Study Completion: 2017-07-06
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

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

Inclusion Criteria

• 1 The diagnosis of persistent BA,established in accordance with GINA,2015,atleast 6monthsprior to the screening visit.
• 2 Need to use SABA more than 2 times per week.
• 3 BA insufficently controlled by the inhaled gluco corticosteroids and short acting Betta 2 adrenoceptor agonists (SABA)as on demand therapy 1 of 2 of the followings items required a) Daytime symptoms more often than 2 times a week.
• b) Night awakenings due to asthma.
• c) Need for medication to relieve symptoms more often than 2 times a week.
• d) Any activity limitation due to BA 4 Patients with of asthma control test scores under the ACQ-5 questionnaire: more thyan or equal to 0.75 points and less than 1.5 points 5 Forced expiratory volume per 1 second (FEV1) index before taking bronchial spasmolytics not less than 60% of the due.
• 6 Positive response to the reversibility test, defined as ΔFEV1 more than or equal to 12% and more than or equal to 200 ml compared to baseline, through 30 minutes after taking 400 µg salbutamol.
• 7 Patients should have used background therapy of BA with iGCS at low doses for at least 1 month prior to the screening visit Drug Daily dosage (µg) Beclomethasone dipropionate200–500 Budesonide 200–400 Fluticasone propionate 100–250 Mometasone furoate 110–220 Ciclesonide 80–160 8 Ability to correctly perform the technique of inhalations of the study product and daily peak flowmetry 9 Patients consent to use reliable contraceptive methods throughout the study and within 3 weeks after it obtained from: a) women with negative pregnancy test and using the following methods of contraception:intrauterine devices, oral contraceptives with low doses of estrogen, barrier method and double barrier protection.
• Women of child-bearing potential (with a history of hysterectomy, tubal ligation, infertility, menopause for more than 1 year) may also participate in the study.
• or b) Men using barrier methods of contraception.
• Men unable to procreate (with a history of vasectomy, infertility) may also participate in the study.
• 10 Signed and dated informed consent to participate in the study.

Exclusion Criteria

• 1.Patients requiring the selection of a starting maintenance therapy of BA.
• 2.Contraindications to treatment with iGCS, hypersensitivity to Budesonide, Formoterol or any components of the study product and reference product.
• 4.Body mass index (BMI) more than 35 kg per meter square.
• 5.The diagnosis of COPD, established under the version of GOLD, 2015.
• 6.Overuse of SABA more than 7 times per week or more than 8 inhalations per day for 2 consecutive days).
• 7.Patients who received oral or parenteral glucocorticosteroids (GCS) within previous 2 months before the screening visit (3 months for parenteral GCS of prolonged action) 8.Conditions, requiring systemic GCS.
• 9.Unexpected and progressive deterioration of control over BA symptoms.
• 10.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).
• 11.Pulmonary tuberculosis (active or inactive form).
• 12.Fungal, viral or bacterial infections of the respiratory tract or systemic viral infections, herpetic lesion of the eye (Herpes simplex).
• 13.Lower respiratory tract infection within 1 month before screening visit 14.Cystic fibrosis, bronchiectasis, pneumoconiosis.
• 16.Uncontrolled hypokalemia, hypocalcaemia.
• 17.Thyrotoxicosis.
• 18.Osteoporosis.
• 19.Glaucoma, cataract 20.Ischemic heart disease, cardiac arrhythmia and conduction disorder, particularly, AV block III degree; chronic heart failure II, III, IV NYHA classes; idiopathic muscular subaortic stenosis; hypertrophic obstructive cardiomyopathy, aortic aneurysm; known or suspected QT interval prolongation.
• 21.Diseases, manifesting with increased bleeding (hemorrhagic diathesis, haemophilia, thrombocytopenia, etc.) or conditions, associated with a high risk of bleeding.
• 22.Impairment of adrenal function.
• 23.Hepatic insufficiency syndrome, confirmed by objective examination and clinical and laboratory data.
• 24.Severe, decompensated or unstable somatic diseases (any diseases or conditions, which threaten the patients life or impair the patients prognosis, and also render the participation of the patient in the clinical trial impossible).
• 25.A history of other malignancies, except for patients in whom the disease was not observed in the last 5 years, patients with a fully cured basal cell carcinoma of the skin or fully cured carcinoma in situ.
• 26.Administration of immunosuppressive drugs within 4 weeks prior to the study (e.g, cyclosporine, methotrexate, or TNF alpha-receptor antibodies or inhibitors, preparations of gold, azathioprine etc.).
• 27.The need for drugs from the list of prohibited therapy.
• 28.Smoking patients or those who smoked in the past more than 10 pack-years (pack-year: number of cigarettes, smoked per day, multiplied by the number of years of smoking per 20) 29.History of alcohol or drug addiction, mental illness.
• 30.Pregnancy, lactation period.
• 31.The patients inability to abide by the terms of this Protocol.
• 32.Participating in another clinical study during the last 3 months.
• 33.Other conditions, which according the physician-investigator preclude from inclusion of the patient in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess the efficacy of therapy with Forb 100 HFA metered dose aerosol for inhalation 100+6 µg/dose in comparison with the product Foradil Combi, set of capsules with inhalation powder	Screening-Day0 to End of Treatment- Day 86
200+12 µg/caps in patients with partially controlled BA.	Screening-Day0 to End of Treatment- Day 86
2.To assess the safety of therapy with Forb 100 HFA, metered dose aerosol for inhalation 100+6 µg/dose in comparison with the product Foradil Combi, set of capsules with inhalation powder 200+12 µg/caps in patients with partially controlled BA.	Screening-Day0 to End of Treatment- Day 86

Secondary Outcome Measures

Name	Time	Method
To assess the effect of the product Forb 100 HFA metered dose aerosol for inhalation compared with foradil combi set of capsules with inhalation powder on the quality of life in patients with partially controlled Asthma.	Screening-Day 0 to End of Treatment- Day 86

Trial Locations

Locations (1)

Dr B.R. Ambedkar Medical College & Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Dr B.R. Ambedkar Medical College & Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Niveditha B Kerodi

Principal investigator

09916070784

nitukerodi@gmail.com