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Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base

NCT03549897 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-06-14

No results posted yet for this study

Summary

This randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90 mcg base (Amneal Ireland Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in patients with stable mild asthma.

Conditions

Interventions

DRUG

Placebo

Placebo Product

DRUG

90 mcg Reference Product

90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]

DRUG

180 mcg Reference Product

180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]

DRUG

90 mcg Test Product

90 mcg Test Product - ALBUTEROL SULFATE HFA \[AMNEAL IRELAND LIMITED\]

Sponsors & Collaborators

  • Amneal Ireland Limited

    lead INDUSTRY

Principal Investigators

  • Irshad Haque · Amneal Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2018-08-31
Completion
2018-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549897 on ClinicalTrials.gov