Trial Outcomes & Findings for Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH (NCT NCT04051710)
NCT ID: NCT04051710
Last Updated: 2020-11-13
Results Overview
Mean change in Forced Expiratory volume in 1 second (FEV 1) from baseline to end of study visit
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1550 participants
Primary outcome timeframe
4 weeks
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
Group I (Test)
One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily.
Test Product: Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
|
Group II
One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Reference) twice daily.
Reference Product: QVAR® Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
|
Group III (Placebo)
One inhalation of Placebo inhalation aerosol twice daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
620
|
620
|
310
|
|
Overall Study
COMPLETED
|
616
|
612
|
306
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH
Baseline characteristics by cohort
| Measure |
Test Group
n=617 Participants
Subjects randomly enrolled into test group received test comparator, Beclomethasone dipropinate, 0.04 mg/INH to administer one inhalation twice daily
|
Reference Group
n=615 Participants
Subjects randomly enrolled into Reference group received Reference comparator, QVAR® containing Beclomethasone dipropinate, 0.04 mg/INH to administer one inhalation twice daily
|
Placebo Group
n=308 Participants
Subjects randomly enrolled into Placebo group received a Placebo device to administer one inhalation twice daily
|
Total
n=1540 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 12.85 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 12.86 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
267 Participants
n=5 Participants
|
272 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
678 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
350 Participants
n=5 Participants
|
343 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
862 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
617 Participants
n=5 Participants
|
615 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
1540 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
617 participants
n=5 Participants
|
615 participants
n=7 Participants
|
308 participants
n=5 Participants
|
1540 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Mean change of FEV1 from baseline to end of study was measured
Mean change in Forced Expiratory volume in 1 second (FEV 1) from baseline to end of study visit
Outcome measures
| Measure |
Group-I (Test)
n=577 Participants
One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily.
Test Product: Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
|
Group-II (Reference)
n=566 Participants
One inhalation of QVAR® 40 mcg (Beclomethasone dipropionate HFA), Inhalation Aerosol twice daily.
Reference Product: Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
|
Group-III (Placebo)
n=282 Participants
One inhalation of Placebo Inhalation Aerosol twice daily.
Placebo: Placebo Product
|
|---|---|---|---|
|
Change in FEV1 From Pre Dose to End of Treatment
|
0.23 Litres
Standard Error 0.01
|
0.22 Litres
Standard Error 0.01
|
0.09 Litres
Standard Error 0.01
|
Adverse Events
Group I (Test)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Group II (Reference)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Group III (Placebo)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group I (Test)
n=619 participants at risk
One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily.
Test Product: Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
|
Group II (Reference)
n=620 participants at risk
One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Reference) twice daily.
Reference Product: QVAR® Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
|
Group III (Placebo)
n=310 participants at risk
One inhalation of Placebo inhalation aerosol twice daily.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.1%
13/619 • 1 year
|
1.1%
7/620 • 1 year
|
1.3%
4/310 • 1 year
|
|
Nervous system disorders
Tremor
|
0.00%
0/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Nervous system disorders
Vertigo
|
0.16%
1/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
7/619 • 1 year
|
0.81%
5/620 • 1 year
|
0.97%
3/310 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.32%
1/310 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.16%
1/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.65%
2/310 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.16%
1/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.32%
2/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.32%
1/310 • 1 year
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/619 • 1 year
|
0.32%
2/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.32%
2/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.65%
2/310 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.16%
1/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
General disorders
Asthenia
|
0.16%
1/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
General disorders
Inflammation
|
0.00%
0/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
General disorders
Pain
|
0.48%
3/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.32%
1/310 • 1 year
|
|
General disorders
Pyrexia
|
0.81%
5/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Infections and infestations
Rhinitis
|
0.16%
1/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.32%
1/310 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.16%
1/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.16%
1/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.65%
2/310 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.16%
1/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Vascular disorders
Migraine
|
0.16%
1/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.00%
0/310 • 1 year
|
|
Investigations
Alanine Aminotransferase increased
|
0.16%
1/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.32%
1/310 • 1 year
|
|
Investigations
Aspartate Aminotransferase increased
|
0.16%
1/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.32%
1/310 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
0.16%
1/619 • 1 year
|
0.00%
0/620 • 1 year
|
0.32%
1/310 • 1 year
|
|
Investigations
white blood cells decreased
|
0.16%
1/619 • 1 year
|
0.16%
1/620 • 1 year
|
0.00%
0/310 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the ownership of all the data generated from the study and PI has no rights to publish the results or any information derived from the study.
- Publication restrictions are in place
Restriction type: OTHER