Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma

January 16, 2017 updated by: AstraZeneca

Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period Complete Crossover Study of the Bronchodilator Effects of Formoterol Fumarate Inhalation Powder in Patients With Mild to Moderate Asthma.

The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma.

This study will include a screening visit followed by a 4 month treatment period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Forest Investigative Site 909
    • California
      • Encinitas, California, United States, 92024
        • Forest Investigative Site 2066
      • Los Angeles, California, United States, 90025
        • Forest Investigative Site 1624
      • Mission Viejo, California, United States, 92691
        • Forest Investigative Site 1995
      • San Jose, California, United States, 95117
        • Forest Investigative Site 1347
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Forest Investigative Site 1996
      • Colorado Springs, Colorado, United States, 80907
        • Forest Investigative Site 1137
      • Denver, Colorado, United States, 80230
        • Forest Investigative Site 1998
    • Florida
      • Tampa, Florida, United States, 33613
        • Forest Investigative Site 2047
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Forest Investigative Site 1536
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Forest Investigative Site 1333
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Forest Investigative Site 1431
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Forest Investigative Site 2041
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Forest Investigative Site 1599
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Forest Investigative Site 1609
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Forest Investigative Site 1999
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Forest Investigative Site 1153
    • Ohio
      • Canton, Ohio, United States, 44718
        • Forest Investigative Site 1134
      • Cincinnati, Ohio, United States, 45231
        • Forest Investigative Site 1806
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Forest Investigative Site 1176
    • Oregon
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site 2043
      • Portland, Oregon, United States, 97202
        • Forest Investigative Site 1580
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Forest Investigative Site 2025
    • Texas
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 1155
      • El Paso, Texas, United States, 79903
        • Forest Investigative Site 1332
      • New Braunfels, Texas, United States, 78130
        • Forest Investigative Site 1370
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 1699
    • Washington
      • Seattle, Washington, United States, 98115
        • Forest Investigative Site 2011
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Forest Investigative Site 1997

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusions:

  • Patients with mild-to-moderate asthma for at least 6 months prior to Visit 1 (as defined in the GINA Guidelines) which is unlikely to exacerbate during the study (e.g., due to seasonal allergen exposure).
  • Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at least 30 days prior to Visit 1. Patients on a combination of ICS/LABA must discontinue the use of LABA and must be on a stable dose of ICS for 30 days prior to Visit 1.
  • Qualifying spirometry at Visit 1 demonstrates highest FEV1 is ≤ 85% and ≥ 60% of predicted for age, height, and gender using NHANES III (NHANES 2010) when bronchodilator medications have been withheld the appropriate length of time per the List of Concomitant Medications (Appendix III)
  • Patient demonstrates reversibility with an increase in FEV1 of 12% and 200 mL after the administration of 360 µg of albuterol.
  • Highest pre-dose FEV1 at Visits 2, 4, 6, 8, and 10 must be within 25% of the qualifying FEV1 at Visit 1

Exclusions:

  • Patients with any clinically significant respiratory conditions other than mild to moderate asthma, such as COPD, active tuberculosis, or history of interstitial lung disease
  • Patients with a severe asthma exacerbation requiring hospitalization in the previous 12 months
  • Patient is not able to withhold use of inhaled short-acting beta-agonist (SABA) for at least 6 hours prior to visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 1
Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose
Drug: Formoterol Fumarate in the Pressair DPI, Low Dose
Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
Experimental: Experimental 2
Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose
Drug: Formoterol Fumarate in the Pressair DPI, High Dose
Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
Active Comparator: Active Comparator 1
Foradil Aerolizer, Low Dose
Drug: Foradil Aerolizer, Low Dose
Foradil Aerolizer 12 micrograms, twice a day for 14 days
Other Names:
  • Formoterol
Active Comparator: Active Comparator 2
Foradil Aerolizer, High Dose
Drug: Foradil Aerolizer, High Dose
Foradil Aerolizer 24 micrograms, twice per day for 14 days
Other Names:
  • Formoterol
Placebo Comparator: Placebo
Dose matched placebo
Drug: Placebo
Placebo in the Pressair for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
Time Frame: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)
Time Frame: Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of Period 1 The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAC-MD-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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