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

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01641081
First received: July 12, 2012
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Formoterol Fumarate in the Pressair DPI, low dose
Drug: Formoterol Fumarate in the Pressair DPI 6 mcg, twice a day for 14 days
Drug: Foradil Aerolizer, low dose
Drug: Foradil Aerolizer, high dose
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change from baseline in normalized Forced Expiratory Volume in One Second (FEV1) area under the curve [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Change from baseline in normalized FEV1 Area Under the Curve (AUC) from time 0 to 6 hours (AUC 0h-6h) after the morning dose of investigational product at Day 14 across treatment periods.


Secondary Outcome Measures:
  • Change from baseline in normalized FEV1 area under the curve [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
    The secondary efficacy parameters are change from baseline in normalized FEV1 area under the curve from time 0 to 6 hours (AUC 0h-6h) after the morning dose of investigational product at Day 1 across treatment periods and change from baseline in FEV1 at each specific time point at Days 1 and 14 across treatment periods.

  • Adverse event (AE) recording [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Number of patients to experience a Treatment Emergent Adverse Event (TEAE)

  • Vital Signs [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight

  • Electrocardiograms (ECGs) [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Number of patients to experience potentially clinically significant changes in ECG from Baseline.

  • Clinical Laboratory Measures [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry, Urinalysis or Theophylline.


Enrollment: 174
Study Start Date: June 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formoterol
Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI)
Drug: Formoterol Fumarate in the Pressair DPI, low dose
Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
Experimental: Formoterol, High Dose
Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI)
Drug: Formoterol Fumarate in the Pressair DPI 6 mcg, twice a day for 14 days
Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
Active Comparator: Foradil
Foradil Aerolizer
Drug: Foradil Aerolizer, low dose
Foradil Aerolizer 12 micrograms, twice a day for 14 days
Active Comparator: Foradil, High Dose
Foradil Aerolizer, high dose
Drug: Foradil Aerolizer, high dose
Foradil Aerolizer 24 micrograms, twice per day for 14 days
Placebo Comparator: Placebo
Dose matched placebo
Drug: Placebo
Placebo in the Pressair for 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641081

  Show 29 Study Locations
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Carrie D'Andrea, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01641081     History of Changes
Other Study ID Numbers: LAC-MD-21
Study First Received: July 12, 2012
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014