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Study of Safety of Foradil in Patients With Persistent Asthma

This study has been terminated.
(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.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01845025
First received: April 22, 2013
Last updated: January 30, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Persistent Asthma Drug: Formoterol 12 mcg Drug: Fluticasone propionate 100 mcg Drug: Fluticasone propionate 250 mcg Drug: Fluticasone propionate 500 mcg Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 [ Time Frame: 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 [ Time Frame: 26 weeks ]
    Number of asthma exacerbations events

  • Percentage of Days of School/Work Missed at 26 Weeks [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline and 26 weeks ]
    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) [ Time Frame: Week 4, Week 12, and 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).


Enrollment: 827
Study Start Date: May 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOM 12 mcg + FP
Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
Drug: Formoterol 12 mcg
Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler
Other Name: FOR258
Drug: Fluticasone propionate 100 mcg
Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
Drug: Fluticasone propionate 250 mcg
Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
Drug: Fluticasone propionate 500 mcg
Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
Active Comparator: fluticasone propionate (FP)
fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
Drug: Fluticasone propionate 100 mcg
Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
Drug: Fluticasone propionate 250 mcg
Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
Drug: Fluticasone propionate 500 mcg
Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
Drug: Placebo
Placebo to match formoterol one inhalation twice daily via dry powder inhaler

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.

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT01845025

  Show 27 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Chrsitopher Compton Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01845025     History of Changes
Other Study ID Numbers: CFOR258D2416
2012-004854-27 ( EudraCT Number )
Study First Received: April 22, 2013
Results First Received: November 10, 2016
Last Updated: January 30, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Asthma
formoterol fumarate
Foradil
inhaled corticosteroid
fluticasone propionate
safety

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
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 August 17, 2017