NCT03528577

Brief Summary

To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_3 asthma

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 22, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

April 21, 2018

Results QC Date

July 18, 2020

Last Update Submit

January 2, 2021

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic Endpoint Post-dose PC20

    The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population.

    Approximately 15 minutes after last inhalation of study product

Study Arms (4)

Test

EXPERIMENTAL

Albuterol Sulfate Inhalation Aerosol, eq 90 mcg

Drug: Zero-doseDrug: 90 mcg of PROAIR® HFADrug: 180 mcg of 90 mcg of PROAIR® HFADrug: 90 mcg of albuterol sulfate inhalation aerosol

Reference

ACTIVE COMPARATOR

PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg

Drug: Zero-doseDrug: 90 mcg of PROAIR® HFADrug: 180 mcg of 90 mcg of PROAIR® HFADrug: 90 mcg of albuterol sulfate inhalation aerosol

Test Placebo

PLACEBO COMPARATOR

Placebo for Albuterol Sulfate Inhalation Aerosol

Drug: Zero-doseDrug: 90 mcg of PROAIR® HFADrug: 180 mcg of 90 mcg of PROAIR® HFADrug: 90 mcg of albuterol sulfate inhalation aerosol

Reference Placebo

PLACEBO COMPARATOR

Placebo for Albuterol Sulfate Inhalation Aerosol

Drug: Zero-doseDrug: 90 mcg of PROAIR® HFADrug: 180 mcg of 90 mcg of PROAIR® HFADrug: 90 mcg of albuterol sulfate inhalation aerosol

Interventions

Zero-doseDRUG

Treatment A

ReferenceReference PlaceboTestTest Placebo
90 mcg of PROAIR® HFADRUG

Treatment B

ReferenceReference PlaceboTestTest Placebo
180 mcg of 90 mcg of PROAIR® HFADRUG

Treatment C

ReferenceReference PlaceboTestTest Placebo
90 mcg of albuterol sulfate inhalation aerosolDRUG

Treatment D

ReferenceReference PlaceboTestTest Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or non-pregnant women 18 to 65 years of age.
  • Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations.
  • Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test
  • Ability to use inhalation aerosol correctly.

You may not qualify if:

  • Any clinically significant finding on physical exam in the opinion of the Investigator, would compromise subject's safety or data integrity.
  • Employees of the Investigator or research center or their immediate family members.
  • Previous participation in this study.
  • Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

SPARC Site 02

Miami Lakes, Florida, 33014, United States

Location

SPARC site 01

Bethesda, Maryland, 20814, United States

Location

SPARC Site 04

St Louis, Missouri, 63141, United States

Location

SPARC Site 06

Gastonia, North Carolina, 28054, United States

Location

SPARC Site 05

Edmond, Oklahoma, 73034, United States

Location

SPARC Site 07

Warwick, Rhode Island, 02886, United States

Location

SPARC Site 08

Boerne, Texas, 78006, United States

Location

SPARC Site 03

Waco, Texas, 76712, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Clinical Trials
Organization
SPIL
clinical.trials@sparcmail.com
912266455645

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2018

First Posted

May 18, 2018

Study Start

September 22, 2018

Primary Completion

March 11, 2019

Study Completion

August 3, 2019

Last Updated

January 22, 2021

Results First Posted

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(8)