A randomized, multiple-dose, double blind, placebo controlled, parallel group, multicentric study to evaluate Efficacy and Safety of Beclomethasone Dipropionate Metered Dose Inhaler (Inhalation Aerosol) (0.04 mg/ INH) in male and/ or female subjects with Asthma [GroupI (Test): Beclomethasone Dipropionate 0.04 mg/ INH; Group II (Reference): QVAR® 40 mcg (Beclomethasone dipropionate HFA); and Group III: Placebo]
Subjects will receive one inhalation (0.04 mg/ INH) of Study medication twice daily
Comparator Agent
Placebo Inhaler
Subjects will receive one inhalation of Study medication twice daily
Comparator Agent
QVAR® 40 mcg (Beclomethasone dipropionate HFA),Inhalation Aerosol
Subjects will receive one inhalation (0.04 mg/ INH) of Study medication twice daily
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Adult male or female subjects of aged ≥18 to ≤ 65 years inclusive.
2. Diagnosis of asthma as defined by the National Asthma Education and Prevention Program at least 12 months prior to screening.
3. Pre-bronchodilator FEV1 of ≥ 45% and ≤ 85% of predicted value during the screening visit and on the first day of treatment visit.
4. ≥15% and > 0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of Salbutamol inhalation (pMDI) on the first day of treatment visit.
5. Subjects with FeNO > 25 ppb at screening and on the first day of treatment visit.
6. Subjects stable on their chronic asthma treatment regimen for at least four weeks prior to enrollment.
7. Subject should able to replace current SABAs with Salbutamol inhaler for use as needed for the duration of the study.
8. Subject should be able to withhold all inhaled SABAs for at least six hours prior to lung function assessments on study visits.
9. Ability to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for remainder of the study.
10. Asthma patients who are stable on low dose ICS or low dose ICS+LABA or who will be stable with low dose ICS as per Investigator’s clinical judgement.
11. Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and having had ≤ 10 pack-years of historical use.
12. Willingness to give their written informed consent to participate in the study.
13. Subjects willing to perform all study related procedures including the use of study inhalers, Spirometry and willing to complete the Subject diary.
14. Female of child-bearing potential, agreed to use a reliable method of contraception during study (e.g., condom + spermicide, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
ExclusionCriteria
Details
1. Life-threatening asthma, a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s).
2. Hospitalizations within the past year prior to the screening for the conditions mentioned in exclusion criteria No.01 or during the run-in period.
3. Significant respiratory disease other than asthma (COPD, interstitial
lung disease, etc.)
4. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension
5. Evidence or history of clinically significant disease or abnormality including uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
6. Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.
7. Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within four weeks prior to the screening, during the run-in period, or on the day of treatment.
8. Hypersensitivity to Beclomethasone or any of the ingredients of the formulation and any sympathomimetic drug (e.g., Salbutamol) or any inhaled, intranasal, or systemic corticosteroid therapy.
9. Subjects receiving β2-blockers, anti-arrhythmics, anti-depressants, and monoamine oxidase inhibitors within 4 weeks prior to the screening.
10. Subjects who required systemic corticosteroids (for any reason) within the past 2 months.
11. Clinically significant abnormalities in ECG at screening as per investigators discretion.
12. Female subjects who are pregnant, nursing or planning a pregnancy during the study.
13. Subjects who have participated in another investigational drug or device research study within 30 days of screening.
14. Subjects who are using any medication or has any disease which in the
judgment of the Investigator will interfere with the conduct or interpretation of the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Mean change in Forced Expiratory volume in 1 second (FEV 1) from baseline (visit 3) to end of study visit (visit 5).
Visit 1, 2, 3, 4 and 5
Secondary Outcome
Outcome
TimePoints
• Mean change in FeNO value from base line (visit 1 & 3) to end of study visit (visit 5)
• Percentage of subjects with reduction of FeNO from Baseline
Visit 1,3,and 5
Target Sample Size
Total Sample Size="1550" Sample Size from India="1550" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="1550"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Subjects meeting all the inclusion criteria and none of the exclusion criteria will be asked to visit the study site for run-in period. Subjects will be provided with placebo metered dose inhaler in the run-in period and will be advised to take one inhalation twice daily for two weeks. Subjects will be required to visit on Day 15 + 1 and those subjects who completed the placebo run period and met the applicable eligible criteria will be randomized. An exhaled nitric oxide (FeNO) test will be performed on day 15 + 1. Pulmonary function test (PFT) by spirometer will be performed. Airway reversibility will be checked. According to the randomization scheme, subjects will be supplied with the study medication (either Test or Reference or Placebo in 2:2:1 ratio as per the randomization schedule) along with diary card with instructions regarding filling of subject diary.
Subjects will be advised to take one inhalation twice daily for 4 weeks in the morning and evening, preferably on the same time period during the entire treatment period. Subjects need to report to the Investigator site on day 21± 1 and 42 ± 2. At these visits (Visit 4 and Visit 5), efficacy and safety evaluation will be done. At the EOS visit (Visit 5), subjects will go through all the end of study evaluation procedures.