A clinical study to evaluate the Efficacy and safety of Generic Fluticasone Propionate Inhalation Aerosol (pMDI, HFA 134a) in patients with Bronchial Asthma.

Phase 3

Recruiting

• Conditions: Mild persistent asthma,

• Registration Number: CTRI/2021/03/032100
• Lead Sponsor: MACLEODS PHARMACEUTICALS LTD

Brief Summary

Thisis a prospective, multi-center, randomized, assessor-blind, parallel-group,comparative clinical endpoint BE study to compare the efficacy and safety ofGeneric Fluticasone propionate inhalation aerosol (pMDI, HFA 134a) (test drug)(of Macleods Pharmaceuticals Ltd.) versus the RLD FLOVENT HFA (pMDI) inhalationaerosol and efficacy and safety of both test and RLD to a placebo-control intreatment of patients with bronchial asthma. It is phase III/Clinical Endpoint Bioequivalence study. There are 6scheduled study site visits during the entire study period; Visit 1 (Screeningperiod/Up to 7 days), Visit 2 (Start Day of run-in period/For 14 days [+3days]), Visit 3 (Randomization/Start of 4-week treatment period/Day 1), Visit 4(Interim study site visit during 4-week treatment period/Day 15 [±2 days]),Visit 5 (End-of-treatment (EOT) study site visit/Day 28 [±1 day]) and Visit 6(End-of-study [EOS] & Safety follow-up visit/Day 35 (±2 days) OR 7thday (±2 days) after last dose day of IP. Telephonic contactswill be established with subject during 4-week treatment with IP on Day 8(±1 day) and Day 21 (±1 day) to remind about the study treatment compliance andsafety. Individual participation of the subject in the study will last forapproximately 62 days. The Investigator must voluntarily confirm subject’s willingnessto participate in the trial after having been informed of all aspects of thetrial that are relevant to the subject’s decision to participate in the trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-20
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 1232

Inclusion Criteria

• Adult male or female subjects aged between 18 to 65 years of age (both ages inclusive) 2.
• Diagnosis of asthma, as defined by the National Asthma Education and Prevention Program (NAEPP) at least 12 months prior to screening 3.
• Pre-bronchodilator FEV1 of more than or equal to 45% and less than or equal to 85% of the predicted normal value during the screening visit 4.
• Subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to screening (Note:-Subject stabilized with dose of more than 250 mcg of Fluticasone should not be included in the study) 5.
• Currently non-smoking; has not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and has less than or equal to 10 pack years of historical use 6.
• More than or equal to 15% and 200 mL reversibility of FEV1 within 30 min following 360 mcg of Albuterol inhalation (pMDI) at screening (Note: Subjects not fulfilling reversibility of FEV1 at screening can be rescheduled for reversibility testing during the entire screening period and up to 1 day prior to randomization) 6 (a) More than or equal to 15% and 200 mL reversibility of FEV1 within 30 min following 360 mcg of Albuterol inhalation (pMDI) prior to randomization 7.
• Ability to discontinue their asthma medication (ICS and long-acting beta agonist) during the run-in period and for remainder of the study in the opinion of the investigator 8.
• Ability to replace short-acting beta agonists (SABAs) ongoing at screening with Salbutamol inhaler for use as needed for the duration of the study in the opinion of the Investigator; subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits 9.
• Women of childbearing potential must be willing to consistently use an appropriate method of contraception 10.
• Willingness to give their written informed consent to participate in the study 11.
• Is willing to comply with all aspects of the protocol 12.
• Ability to follow training given for study related procedures and assessments in the opinion of the Investigator.

Exclusion Criteria

• Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year prior to the screening 2.
• Significant respiratory disease other than asthma 3.
• Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus (HbA1c more than 10%) uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
• In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, cardiovascular, endocrine, or other diseases that, in the opinion of the investigator, would put the subject at risk through study period, or would affect the study analyses if the disease exacerbates during the study 4.Known hypersensitivity to any sympathomimetic drug (e.g., Salbutamol/Albuterol) or to any inhaled, intranasal, or systemic corticosteroid therapy, or to propellant HFA-134a (1,1,1,2- tetrafluoroethane) 5.
• Subjects receiving B2-blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to the screening 6.
• Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within 4 weeks prior to the screening visit 7.
• Subjects who required systemic or oral corticosteroids (for any reason) within the past 6 months prior to screening 8.
• Evidence or history of oral candidiasis, tuberculosis, hypercorticism, adrenal suppression, or eye problems 9.
• Subjects scheduled for pre-planned surgery during the treatment period or in the opinion of the Investigator is expected to undergo surgery based on their medical history details at the time of screening 10.
• Female subjects who are pregnant or breast-feeding or planning to be pregnant & Participation in another clinical trial within 3 months before screening, History or current drug substance abuse 11.Subjects with history or current significant alcohol consumption which as per investigators judgment, make the subject ineligible to participate in the study 12.Any other medical, surgical,psychiatric conditions or laboratory abnormalities that would patient at risk through study participation,which as per investigators judgment,make the subject ineligible to participate in the study or may increase potential risk for subject associated with study participation or that may affect study results interpretation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period (test versus placebo and RLD versus placebo).	last day of 4-week treatment period
Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period (test versus RLD)	last day of 4-week treatment period

Secondary Outcome Measures

Name	Time	Method
Average use of rescue medications during the 4-week treatment period	4-week

Trial Locations

Locations (39)

A.C.S.R. Govt Medical College & Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

ACE Hospital and Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Apollo Specialty Hospital Pvt Ltd; 🇮🇳 Nagar, UTTAR PRADESH, India

Ashirwad Hospital and Research centre; 🇮🇳 Thane, MAHARASHTRA, India

Asian Institute Of Medical Sciences; 🇮🇳 Thane, MAHARASHTRA, India

Asthma Bhawan; 🇮🇳 Jaipur, RAJASTHAN, India

Aware Gleneagles Global Hospital; 🇮🇳 Hyderabad, TELANGANA, India

BGS Global Institute of Medical Sciences and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Criticare Hospital & Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

Down town Hospital; 🇮🇳 Kamrup, ASSAM, India

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A.C.S.R. Govt Medical College & Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Dr SK Noushad Ali

Principal investigator

mddbnoal@gmail.com