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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Foradil Aerolizer, High Dose; Drug: Formoterol Fumarate in the Pressair DPI, Low Dose; Drug: Foradil Aerolizer, Low Dose; Drug: Formoterol Fumarate in the Pressair DPI, High Dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01641081

LAC-MD-21

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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174 participants in 5 patient groups, including a placebo group

Experimental 1

Experimental group

Description:

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

Treatment:

Drug: Formoterol Fumarate in the Pressair DPI, Low Dose

Experimental 2

Experimental group

Description:

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

Treatment:

Drug: Formoterol Fumarate in the Pressair DPI, High Dose

Active Comparator 1

Active Comparator group

Description:

Foradil Aerolizer, Low Dose

Treatment:

Drug: Foradil Aerolizer, Low Dose

Active Comparator 2

Active Comparator group

Description:

Foradil Aerolizer, High Dose

Treatment:

Drug: Foradil Aerolizer, High Dose

Placebo

Placebo Comparator group

Description:

Dose matched placebo

Treatment:

Drug: Placebo