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Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler

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ClinicalTrials.gov Identifier: NCT02980133
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
This study is to evaluate the safety and efficacy of Fluticasone Propionate and Fluticasone propionate Salmeterol in pediatric patients with a documented history of persistent asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fp MDPI Drug: FS MDPI Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years With Persistent Asthma
Actual Study Start Date : December 16, 2016
Estimated Primary Completion Date : September 18, 2018
Estimated Study Completion Date : October 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment group A
Fp MDPI- Dose Regimen 1
Drug: Fp MDPI
Experimental: Treatment Group B
Fp MDPI- Dose Regimen 2
Drug: Fp MDPI
Experimental: Treatment Group C
FS MDPI
Drug: FS MDPI
Placebo Comparator: Treatment Group D
Matching placebo
Drug: Placebo



Primary Outcome Measures :
  1. For Fp MDPI versus placebo: the change from baseline in weekly average of the percent predicted trough morning forced expiratory volume in 1 second (FEV1) at week 12 [ Time Frame: Baseline - Week 12 ]
  2. For FS MDPI versus Fp MDPI: the change from baseline in 1-hour postdose percent predicted morning FEV1 at week 12 [ Time Frame: Baseline - Week 12 ]

Secondary Outcome Measures :
  1. Change from baseline in the weekly average of daily trough morning (predose and pre-rescue bronchodilator) PEF over the 12-week treatment period [ Time Frame: Baseline - Week 12 ]
  2. Change from baseline in the weekly average of total daily (24-hour) use of albuterol/salbutamol inhalation aerosol (number of inhalations) over weeks 1 through 12 [ Time Frame: Week 1 - Week 12 ]
  3. Change from baseline in the weekly average of the total daily asthma symptom score (defined as the average of the daytime and nighttime scores) over weeks 1 through 12 [ Time Frame: Week 1 - Week 12 ]
  4. Change from baseline in asthma control (measured by Childhood Asthma Control Test [C-ACT]) over the 12-week treatment period [ Time Frame: Week 1 - Week 12 ]
  5. Time to first onset of effect defined as the first decrease from baseline in daily rescue medication use [ Time Frame: Baseline - Week 12 ]
  6. Proportion of patients discontinued from IMP for asthma exacerbation during the 12-week treatment period [ Time Frame: Week 1 - Week 12 ]


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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a diagnosis of asthma as defined by the NIH
  • The patient has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for age, height, sex, and race at the screening visit (SV).
  • The patient's persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV.
  • The patient (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device
  • The patient (with assistance from parents/legal guardians/caregivers, as needed) is able to use an MDI device and an MDPI device.
  • All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol at the SV for use as needed for the duration of the study

    • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The patient has a history of life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.
  • The patient is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the patient's last study-related visit.
  • The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the IMP or rescue medication formulation (ie, lactose).
  • The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin) within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study.
  • The patient currently smokes or has a smoking history. The patient must not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
  • The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV or has had any hospitalization for asthma within 2 months before the SV.
  • The patient has used immunosuppressive medications within 30 days before the screening visit.
  • The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the run-in period.
  • The patient has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection.
  • The patient is an immediate relative of an employee of the clinical investigational center.
  • A member of the patient's household is participating in the study at the same time
  • Vulnerable patients (ie, people kept in detention) are excluded from participation.

    • Additional criteria apply, please contact the investigator for more information

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): NCT02980133


Contacts
Contact: Teva U.S. Medical Information 1-888-483-8279 ustevatrials@tevapharm.com

  Show 108 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD TEVA

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02980133     History of Changes
Other Study ID Numbers: FSS-AS-30003
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Diseases
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists