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Study of Safety of Foradil in Patients With Persistent Asthma

Primary Purpose

Persistent Asthma

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Formoterol 12 mcg
Fluticasone propionate 100 mcg
Fluticasone propionate 250 mcg
Fluticasone propionate 500 mcg
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Asthma focused on measuring Asthma, formoterol fumarate, Foradil, inhaled corticosteroid, fluticasone propionate, safety

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Written informed consent, and assent if applicable, must be obtained before any assessment is performed.
  2. Male or female patients 12 years of age and older
  3. Confirmed diagnosis of persistent asthma, as defined by national and international asthma guidelines (e.g., GINA; NIH; etc.) for at least 1 year prior to study enrollment.
  4. PEF≥50% of predicted normal value.
  5. Current and appropriate use of one of the treatments listed in the protocol for asthma.
  6. Recent asthma exacerbation between 30 days and 12 months prior to randomization that either:

    • required treatment with systemic corticosteroids (tablets, suspension, or injection) or
    • required hospitalization (defined as an inpatient stay or >24-hour stay in an observation area in an emergency room or other equivalent facility)

Key Exclusion Criteria:

  1. History of life-threatening asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support.
  2. Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma.
  3. Current evidence of, or past physician assessment of, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
  4. History of smoking ≥ 10 pack years.
  5. Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine.
  6. Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved at randomization.
  7. Worsening/Unstable asthma within 7 days prior to randomization.
  8. Any asthma exacerbation requiring systemic corticosteroids within 30 days of randomization or more than 4 separate exacerbations in the 12 months preceding randomization.
  9. Two or more hospitalizations for greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization.
  10. History of hypersensitivity to any beta2-agonist, sympathomimetic drug, inhaled corticosteroids, or systemic corticosteroid therapy or any component of the possible study treatments in this trial, including severe milk protein hypersensitivity.
  11. Use of anti-IgE (e.g., omalizumab) or any other monoclonal antibody, in the 6 months prior to randomization.
  12. Use of (Beta) β-blockers within 1 day prior to first dose of study medication.
  13. Use of ICS, LABA, ICS+LABA, LTRAs, leukotriene modifiers, anticholinergics, or theophylline must be discontinued prior to the first dose of investigational treatment.
  14. Use of a potent CYP3A4 inhibitor within 4 weeks of randomization (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin).

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FOM 12 mcg + FP

fluticasone propionate (FP)

Arm Description

Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation

fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation

Outcomes

Primary Outcome Measures

Number of First Occurrence(s) of Any Composite Endpoint Including Asthma-related Hospitalizations, Intubations and Deaths During the Study at 26 Weeks
The primary safety endpoint was the number of first occurrence(s) of any composite endpoint. The composite events include asthma-related deaths, asthma-related intubations and asthma-related hospitalizations. The number of events includes all adjudication confirmed events, one patient could experience multiple events during the course of study; Event rate = 100 * n patients with any events / total N patients in treatment group.

Secondary Outcome Measures

Number of Asthma Exacerbations at 26 Weeks
Number of asthma exacerbations events
Percentage of Days of School/Work Missed at 26 Weeks
The percentage of days of school/work missed during the treatment period (26 weeks). Overall percentage of school days missed for each student patient or of work days missed is calculated by total number of days missed divided by total days of treatment.
Percentage of Days With Limited Ability to Perform Normal Daily Activities at 26 Weeks
The percentage of days with limited ability to perform normal daily activities during the treatment period (26 weeks). Percentage is calculated as total number of days when the patient had limited ability to perform normal daily activities divided by total days of treatment.
Percentage of Days With Nighttime Awakenings at 26 Weeks
Percentage of days with nighttime awakenings during the treatment period (26 weeks)
Percentage of Days With no Rescue Medication Use at 26 Weeks
Percentage of rescue free days is calculated as total number of days with no rescue medication was taken divided by total days of treatment.
Percentage of Days With no Symptoms at 26 Weeks
Percentage of days with no symptoms during the treatment period (26 weeks). Percentage is calculated as total number of days with no symptoms divided by total days of treatment.
Change From Baseline in Asthma Control Questionnaire (ACQ - 6) Total Score at Week 26
Change from baseline in Asthma control Questionnaire (ACQ - 6) total score at week 26. Results of the Asthma control questionnaire (ACQ-6); The average score of the six questions is calculated as the sum of scores divided by the number of questions that were answered at the time point, as long as there were at least 4 questions answered. The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a total score of 0 corresponds to no impairment and a total score of 6 corresponds to maximum impairment.
Unplanned Healthcare Utilization at Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 26)
Unplanned healthcare utilization by visit (Telephone contact with study doctor (MD); Telephone contact with other physician (MD) or healthcare provider (HCP); Unscheduled or unplanned visit to study doctor (including home visits); Unscheduled or unplanned visit to other physician or healthcare provider (including home visits); Emergency department or hospital visit (< 24 hours); Hospital admission or Emergency department visit (> 24 hours).

Full Information

First Posted
April 22, 2013
Last Updated
January 30, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01845025
Brief Title
Study of Safety of Foradil in Patients With Persistent Asthma
Official Title
A 26 Week, Randomized, Active-controlled Safety Study of Double-blind Formoterol Fumarate in Free Combination With an Inhaled Corticosteroid Versus an Inhaled Corticosteroid in Adolescent and Adult Patients With Persistent Asthma.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to the action to withdraw the Foradil Aerolizer NDA in US; study was discontinued. This was a commercial reason and not due to any change in benefit-risk.
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone propionate alone.
Detailed Description
This was a 26 week, double blind, randomized, active-controlled safety study of Foradil in free combination with inhaled corticosteroid versus an inhaled corticosteroid alone in adults and adolescent patients with persistent asthma. The primary objective of the study was to demonstrate that the addition of formoterol fumarate to fluticasone propionate is non-inferior to fluticasone propionate alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death). The individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation and asthma-related death) will be assessed as a secondary safety endpoints. The efficacy assessment is the secondary objective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Asthma
Keywords
Asthma, formoterol fumarate, Foradil, inhaled corticosteroid, fluticasone propionate, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
827 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOM 12 mcg + FP
Arm Type
Experimental
Arm Description
Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
Arm Title
fluticasone propionate (FP)
Arm Type
Active Comparator
Arm Description
fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
Intervention Type
Drug
Intervention Name(s)
Formoterol 12 mcg
Other Intervention Name(s)
FOR258
Intervention Description
Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate 100 mcg
Intervention Description
Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate 250 mcg
Intervention Description
Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate 500 mcg
Intervention Description
Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match formoterol one inhalation twice daily via dry powder inhaler
Primary Outcome Measure Information:
Title
Number of First Occurrence(s) of Any Composite Endpoint Including Asthma-related Hospitalizations, Intubations and Deaths During the Study at 26 Weeks
Description
The primary safety endpoint was the number of first occurrence(s) of any composite endpoint. The composite events include asthma-related deaths, asthma-related intubations and asthma-related hospitalizations. The number of events includes all adjudication confirmed events, one patient could experience multiple events during the course of study; Event rate = 100 * n patients with any events / total N patients in treatment group.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Number of Asthma Exacerbations at 26 Weeks
Description
Number of asthma exacerbations events
Time Frame
26 weeks
Title
Percentage of Days of School/Work Missed at 26 Weeks
Description
The percentage of days of school/work missed during the treatment period (26 weeks). Overall percentage of school days missed for each student patient or of work days missed is calculated by total number of days missed divided by total days of treatment.
Time Frame
26 weeks
Title
Percentage of Days With Limited Ability to Perform Normal Daily Activities at 26 Weeks
Description
The percentage of days with limited ability to perform normal daily activities during the treatment period (26 weeks). Percentage is calculated as total number of days when the patient had limited ability to perform normal daily activities divided by total days of treatment.
Time Frame
26 weeks
Title
Percentage of Days With Nighttime Awakenings at 26 Weeks
Description
Percentage of days with nighttime awakenings during the treatment period (26 weeks)
Time Frame
26 weeks
Title
Percentage of Days With no Rescue Medication Use at 26 Weeks
Description
Percentage of rescue free days is calculated as total number of days with no rescue medication was taken divided by total days of treatment.
Time Frame
26 weeks
Title
Percentage of Days With no Symptoms at 26 Weeks
Description
Percentage of days with no symptoms during the treatment period (26 weeks). Percentage is calculated as total number of days with no symptoms divided by total days of treatment.
Time Frame
26 weeks
Title
Change From Baseline in Asthma Control Questionnaire (ACQ - 6) Total Score at Week 26
Description
Change from baseline in Asthma control Questionnaire (ACQ - 6) total score at week 26. Results of the Asthma control questionnaire (ACQ-6); The average score of the six questions is calculated as the sum of scores divided by the number of questions that were answered at the time point, as long as there were at least 4 questions answered. The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a total score of 0 corresponds to no impairment and a total score of 6 corresponds to maximum impairment.
Time Frame
baseline and 26 weeks
Title
Unplanned Healthcare Utilization at Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 26)
Description
Unplanned healthcare utilization by visit (Telephone contact with study doctor (MD); Telephone contact with other physician (MD) or healthcare provider (HCP); Unscheduled or unplanned visit to study doctor (including home visits); Unscheduled or unplanned visit to other physician or healthcare provider (including home visits); Emergency department or hospital visit (< 24 hours); Hospital admission or Emergency department visit (> 24 hours).
Time Frame
Week 4, Week 12, and Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Written informed consent, and assent if applicable, must be obtained before any assessment is performed. Male or female patients 12 years of age and older Confirmed diagnosis of persistent asthma, as defined by national and international asthma guidelines (e.g., GINA; NIH; etc.) for at least 1 year prior to study enrollment. PEF≥50% of predicted normal value. Current and appropriate use of one of the treatments listed in the protocol for asthma. Recent asthma exacerbation between 30 days and 12 months prior to randomization that either: required treatment with systemic corticosteroids (tablets, suspension, or injection) or required hospitalization (defined as an inpatient stay or >24-hour stay in an observation area in an emergency room or other equivalent facility) Key Exclusion Criteria: History of life-threatening asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support. Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma. Current evidence of, or past physician assessment of, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease. History of smoking ≥ 10 pack years. Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine. Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved at randomization. Worsening/Unstable asthma within 7 days prior to randomization. Any asthma exacerbation requiring systemic corticosteroids within 30 days of randomization or more than 4 separate exacerbations in the 12 months preceding randomization. Two or more hospitalizations for greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization. History of hypersensitivity to any beta2-agonist, sympathomimetic drug, inhaled corticosteroids, or systemic corticosteroid therapy or any component of the possible study treatments in this trial, including severe milk protein hypersensitivity. Use of anti-IgE (e.g., omalizumab) or any other monoclonal antibody, in the 6 months prior to randomization. Use of (Beta) β-blockers within 1 day prior to first dose of study medication. Use of ICS, LABA, ICS+LABA, LTRAs, leukotriene modifiers, anticholinergics, or theophylline must be discontinued prior to the first dose of investigational treatment. Use of a potent CYP3A4 inhibitor within 4 weeks of randomization (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chrsitopher Compton
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Avondale
State/Province
Arizona
ZIP/Postal Code
85323
Country
United States
Facility Name
Novartis Investigative Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Novartis Investigative Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Novartis Investigative Site
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30012
Country
United States
Facility Name
Novartis Investigative Site
City
Stone Mountain
State/Province
Georgia
ZIP/Postal Code
30083
Country
United States
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40214
Country
United States
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Novartis Investigative Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Novartis Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Novartis Investigative Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20878
Country
United States
Facility Name
Novartis Investigative Site
City
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Novartis Investigative Site
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Novartis Investigative Site
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
Facility Name
Novartis Investigative Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Novartis Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Novartis Investigative Site
City
Oaks
State/Province
Pennsylvania
ZIP/Postal Code
19456
Country
United States
Facility Name
Novartis Investigative Site
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Novartis Investigative Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Novartis Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38118
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Novartis Investigative Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Novartis Investigative Site
City
Mequon
State/Province
Wisconsin
ZIP/Postal Code
53092
Country
United States
Facility Name
Novartis Investigative Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53172
Country
United States

12. IPD Sharing Statement

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Study of Safety of Foradil in Patients With Persistent Asthma

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