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

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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

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

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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