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A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528577
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Zero-dose Drug: 90 mcg of PROAIR® HFA Drug: 180 mcg of 90 mcg of PROAIR® HFA Drug: 90 mcg of albuterol sulfate inhalation aerosol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study 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
Actual Study Start Date : September 22, 2018
Actual Primary Completion Date : March 11, 2019
Actual Study Completion Date : August 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Test
Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
Drug: Zero-dose
Treatment A

Drug: 90 mcg of PROAIR® HFA
Treatment B

Drug: 180 mcg of 90 mcg of PROAIR® HFA
Treatment C

Drug: 90 mcg of albuterol sulfate inhalation aerosol
Treatment D

Active Comparator: Reference
PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
Drug: Zero-dose
Treatment A

Drug: 90 mcg of PROAIR® HFA
Treatment B

Drug: 180 mcg of 90 mcg of PROAIR® HFA
Treatment C

Drug: 90 mcg of albuterol sulfate inhalation aerosol
Treatment D

Placebo Comparator: Test Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
Drug: Zero-dose
Treatment A

Drug: 90 mcg of PROAIR® HFA
Treatment B

Drug: 180 mcg of 90 mcg of PROAIR® HFA
Treatment C

Drug: 90 mcg of albuterol sulfate inhalation aerosol
Treatment D

Placebo Comparator: Reference Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
Drug: Zero-dose
Treatment A

Drug: 90 mcg of PROAIR® HFA
Treatment B

Drug: 180 mcg of 90 mcg of PROAIR® HFA
Treatment C

Drug: 90 mcg of albuterol sulfate inhalation aerosol
Treatment D




Primary Outcome Measures :
  1. pharmacodynamic endpoint post-dose PC20 [ Time Frame: 21 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528577


Locations
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United States, Florida
SPARC Site 02
Miami Lakes, Florida, United States, 33014
United States, Maryland
SPARC site 01
Bethesda, Maryland, United States, 20814
United States, Missouri
SPARC Site 04
Saint Louis, Missouri, United States, 63141
United States, North Carolina
SPARC Site 06
Gastonia, North Carolina, United States, 28054
United States, Oklahoma
SPARC Site 05
Edmond, Oklahoma, United States, 73034
United States, Rhode Island
SPARC Site 07
Warwick, Rhode Island, United States, 02886
United States, Texas
SPARC Site 08
Boerne, Texas, United States, 78006
SPARC Site 03
Waco, Texas, United States, 76712
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited

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Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT03528577     History of Changes
Other Study ID Numbers: CLR_17_08
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Procaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics