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

NCT01641081 | Completed Phase 2 Results

• 1 other identifier: LAC-MD-21
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)

  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 Outcomes (1)

• Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)

  Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment

Study Arms (5)

Experimental 1

EXPERIMENTAL

Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose

Drug: Formoterol Fumarate in the Pressair DPI, Low Dose

Experimental 2

EXPERIMENTAL

Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose

Drug: Formoterol Fumarate in the Pressair DPI, High Dose

Active Comparator 1

ACTIVE COMPARATOR

Foradil Aerolizer, Low Dose

Drug: Foradil Aerolizer, Low Dose

Active Comparator 2

ACTIVE COMPARATOR

Foradil Aerolizer, High Dose

Drug: Foradil Aerolizer, High Dose

Placebo

PLACEBO COMPARATOR

Dose matched placebo

Drug: Placebo

Interventions

Formoterol Fumarate in the Pressair DPI, Low Dose DRUG

Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days

Experimental 1

Formoterol Fumarate in the Pressair DPI, High Dose DRUG

Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days

Experimental 2

Foradil Aerolizer, Low Dose DRUG

Foradil Aerolizer 12 micrograms, twice a day for 14 days

Also known as: Formoterol

Active Comparator 1

Foradil Aerolizer, High Dose DRUG

Foradil Aerolizer 24 micrograms, twice per day for 14 days

Also known as: Formoterol

Active Comparator 2

Placebo DRUG

Placebo in the Pressair for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (29)

Forest Investigative Site 909

Phoenix, Arizona, 85006, United States

Location

Forest Investigative Site 2066

Encinitas, California, 92024, United States

Location

Forest Investigative Site 1624

Los Angeles, California, 90025, United States

Location

Forest Investigative Site 1995

Mission Viejo, California, 92691, United States

Location

Forest Investigative Site 1347

San Jose, California, 95117, United States

Location

Forest Investigative Site 1996

Centennial, Colorado, 80112, United States

Location

Forest Investigative Site 1137

Colorado Springs, Colorado, 80907, United States

Location

Forest Investigative Site 1998

Denver, Colorado, 80230, United States

Location

Forest Investigative Site 2047

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 1536

Louisville, Kentucky, 40215, United States

Location

Forest Investigative Site 1333

Baltimore, Maryland, 21236, United States

Location

Forest Investigative Site 1431

North Dartmouth, Massachusetts, 02747, United States

Location

Forest Investigative Site 2041

Minneapolis, Minnesota, 55402, United States

Location

Forest Investigative Site 1599

St Louis, Missouri, 63141, United States

Location

Forest Investigative Site 1609

Bellevue, Nebraska, 68123, United States

Location

Forest Investigative Site 1999

Skillman, New Jersey, 08558, United States

Location

Forest Investigative Site 1153

Raleigh, North Carolina, 27607, United States

Location

Forest Investigative Site 1134

Canton, Ohio, 44718, United States

Location

Forest Investigative Site 1806

Cincinnati, Ohio, 45231, United States

Location

Forest Investigative Site 1176

Oklahoma City, Oklahoma, 73120, United States

Location

Forest Investigative Site 2043

Medford, Oregon, 97504, United States

Location

Forest Investigative Site 1580

Portland, Oregon, 97202, United States

Location

Forest Investigative Site 2025

Charleston, South Carolina, 29407, United States

Location

Forest Investigative Site 1155

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 1332

El Paso, Texas, 79903, United States

Location

Forest Investigative Site 1370

New Braunfels, Texas, 78130, United States

Location

Forest Investigative Site 1699

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 2011

Seattle, Washington, 98115, United States

Location

Forest Investigative Site 1997

Madison, Wisconsin, 53792, United States

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Study Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Esther Garcia, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 12, 2012
• First Posted: July 16, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 28, 2017
• Results First Posted: December 22, 2016

Record last verified: 2017-01

Locations

US (29)