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.
- Conditions
- Health Condition 1: J40-J47- Chronic lower respiratory diseases
- Registration Number
- CTRI/2017/05/008531
- Lead Sponsor
- RUS Biopharm LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 116
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 Î?FEV1 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 dipropionate200â??500
Budesonide 200â??400
Fluticasone propionate 100â??250
Mometasone furoate 110â??220
Ciclesonide 80â??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.
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.
3.Lactase deficiency, lactose intolerance or glucose-galactose malabsorption.
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.
15.Restrictive disorders of pulmonary ventilation.
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
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 <br/ ><br>200+12 µg/caps in patients with partially controlled BA. <br/ ><br>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.Timepoint: Screening-Day0 to End of Treatment- Day 86 <br/ ><br>
- 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.Timepoint: Screening-Day 0 to End of Treatment- Day 86