| CTRI Number |
CTRI/2017/05/008531 [Registered on: 11/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
Open Label, Multicenter, Randomized, Comparative study to Evaluate the efficacy and safety of drugs Forb 100 HFA (Generic name: Budesonide+Formoterol), metered dose aerosol for inhalation100+6 µg/dose (Midas Care Pharmaceuticals Pvt. Ltd., India) and Foradil Combi, set of capsules with inhalation powder 200+12 µg/caps (dose) (Novartis Pharma AG, Switzerland) in patients with partially controlled asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| protocol no. MA/0715-4 Version 1.0 dated 14.08 2015 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niveditha B Kerodi |
| Designation |
Physician and Senior Resident |
| Affiliation |
Dr B.R. Ambedkar Medical College and Hospital |
| Address |
Dr B.R. Ambedkar Medical College and Hospital
General Medicine department Tannery,shampura,
Kadugondanahalli
Bangalore
KARNATAKA
560045
India |
| Phone |
09916070784 |
| Fax |
|
| Email |
nitukerodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
ICBio Clinical Research Pvt. Ltd
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
ICBio Clinical research Pvt.ltd
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
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Source of Monetary or Material Support
|
| RUS Biopharm LLC
664009 Russia,
Irkutsk,Shiriamova str.36 office 206 |
|
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Primary Sponsor
|
| Name |
RUS Biopharm LLC |
| Address |
Irkutsk,Shiriamova str., 36, Office 206
Russia,664009
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India
Russian Federation |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Niveditha B Kerodi |
Dr B.R. Ambedkar Medical College & Hospital |
General medicine Department,
Tannery,Shampura, Kadugondanahalli
medicinal department
Bangalore
KARNATAKA |
09916070784
nitukerodi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Dr B.R Ambedkar medical college |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J40-J47||Chronic lower respiratory diseases, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foradil Combi |
Foradil Combi, set of capsules with inhalation powder 200+12 µg/caps
Dose: 1 inhalation 200+12 µg/dose, 2 times a day for 86 days |
| Intervention |
Forb 100 HFA |
Generic name: Budesonide+Formoterol, metered dose aerosol for inhalation 100+6 µg per dose, 2 inhalations, 100+6 µg/dose each, 2 times a day for 86 days |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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 dipropionate 200–500
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. |
|
| ExclusionCriteria |
| Details |
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 from inclusion of the patient in the study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
200+12 µg/caps in patients with partially controlled BA.
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
|
| Outcome |
TimePoints |
| 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 |
|
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Target Sample Size
|
Total Sample Size="140"
Sample Size from India="116"
Final Enrollment numbers achieved (Total)= "116"
Final Enrollment numbers achieved (India)="116" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2017 |
| Date of Study Completion (India) |
07/06/2017 |
| Date of First Enrollment (Global) |
02/02/2017 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="19" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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 .
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