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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01641081
First Posted: July 16, 2012
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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, High Dose Drug: Foradil Aerolizer, Low Dose Drug: Foradil Aerolizer, High Dose Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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: 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 Name: 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 Name: Formoterol
Placebo Comparator: Placebo
Dose matched placebo
Drug: Placebo
Placebo in the Pressair for 14 days

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641081


  Show 29 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Esther Garcia, MD AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01641081     History of Changes
Other Study ID Numbers: LAC-MD-21
First Submitted: July 12, 2012
First Posted: July 16, 2012
Results First Submitted: October 27, 2016
Results First Posted: December 22, 2016
Last Update Posted: February 28, 2017
Last Verified: January 2017

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