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Study of Safety of Foradil in Patients With Persistent Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01845025
First received: April 22, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

The purpose of this study is 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 is the same as those taking inhaled fluticasone propionate alone.


Condition Intervention Phase
Persistent Asthma
Drug: Formoterol
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • Combined serious asthma related events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    Combined number of asthma-related hospitalization, asthma-related intubation, and asthma-related death.


Secondary Outcome Measures:
  • Asthma-related hospitalization [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    Number of asthma-related hospitalizations.

  • Asthma-related intubation [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    Number of asthma-related intubation events

  • Asthma-related deaths [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    Number of asthma-related deaths

  • Rescue medication use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Frequency of rescue medication use during study period

  • Symptom and rescue-free days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Number of symptom and rescue-free days per patient

  • Nighttime awakenings [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Number of nighttime awakenings per patient

  • Asthma control Questionnaire (ACQ - 6) score [ Time Frame: baseline and 26 weks ] [ Designated as safety issue: No ]
    Change in Asthma control Questionnaire (ACQ - 6) score from baseline


Estimated Enrollment: 11700
Study Start Date: May 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formoterol + fluticasone propionate 100 mcg
Formoterol 12 mcg + fluticasone propionate 100 mcg
Drug: Formoterol
Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler
Drug: Fluticasone propionate 100 mcg
Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
Experimental: Formoterol + fluticasone propionate 250 mcg
Formoterol 12 mcg + fluticasone propionate 250 mcg
Drug: Formoterol
Formoterol 12 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
Experimental: Formoterol + fluticasone propionate 500 mcg
Formoterol 12 mcg + fluticasone propionate 500 mcg
Drug: Formoterol
Formoterol 12 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 100 mcg
Placebo + fluticasone propionate 100 mcg
Drug: Placebo
Placebo to formoterol one inhalation twice daily via dry powder inhaler
Active Comparator: Fluticasone propionate 250 mcg
Placebo + fluticasone propionate 250 mcg
Drug: Placebo
Placebo to formoterol one inhalation twice daily via dry powder inhaler
Active Comparator: Fluticasone propionate 500 mcg
Placebo + fluticasone propionate 500 mcg
Drug: Placebo
Placebo to formoterol one inhalation twice daily via dry powder inhaler

Detailed Description:

This is 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 is 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

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

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 112 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Chrsitopher Compton Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01845025     History of Changes
Other Study ID Numbers: CFOR258D2416
Study First Received: April 22, 2013
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Asthma, formoterol fumarate, Foradil, inhaled corticosteroid, fluticasone propionate, safety
Asthma
formoterol fumarate
Foradil
inhaled corticosteroid
fluticasone propionate
safety

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

ClinicalTrials.gov processed this record on November 25, 2014