Study of FLUTIFORM® VS Seretide® in Paediatric Subjects With Asthma

Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild to moderate persistent asthma in pediatric subjects.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)

Detailed Description

This is a study involving a 12 week treatment phase followed by a 6 month extension phase. During the treatment phase subjects receive FLUTIFORM® or Seretide®. In the extension phase all subjects receive FLUTIFORM®. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
• France
  • Laon, France
• Germany
  • Wiesal, Germany
• Hungary
  • Budapest, Hungary
• Poland
  • W. Chodzki 2
    • Lublin 20-093, W. Chodzki 2, Poland
• Romania
  • Bucharest, Romania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients between 4-12 years of age. Female patients must be pre-menarche to be eligible.
• Known history of mild to moderate reversible asthma for ≥ 6 months prior to the screening visit.

• Demonstrate a FEV1 of ≥60% to ≤80% of predicted normal values (Zapletal, 1977) during the screening phase following appropriate withholding of asthma medications (if applicable).

  • No beta agonist use on day of screening.
  • No use of combination asthma therapy on day of screening.
  • Inhaled corticosteroids are allowed on day of screening.
• Documented reversibility of ≥ 15% in FEV1 during the screening phase.
• Demonstrate satisfactory technique in the use of the pressurized MDI and spacer device.
• Willing and able to enter information in the electronic diary (parental help is acceptable for young children) and attend all study visits.
• Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
• Written informed parental consent obtained, and where possible informed assent from the patient.

Exclusion Criteria:

• Life-threatening asthma within the past year. This category includes those patients with a history of near-fatal asthma, a hospitalization or an emergency visit for asthma or prior intubation for asthma.
• History of systemic (injectable) corticosteroid medication within 1 month before the Screening Visit.
• History of leukotriene receptor antagonist use, e.g. montelukast, within the past week.
• Current evidence or history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, or cardiac dysrhythmia. 'Clinically significant' is defined as any disease that, in the opinion of the Investigator, would put the patient at risk through study participation, or which would affect the outcome of the study.
• An upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
• Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
• Known Human Immunodeficiency Virus (HIV)-positive status.
• Current smoking history within 12 months prior to the Screening Visit.
• Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
• Patients who have taken B-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
• Current use of medications that will have an effect on bronchospasm and/or pulmonary function.
• Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components.
• Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
• Current participation in a clinical study.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
FEV1, recorded at visits to investigator at 2 wks, 6wks & 12 wks.

Secondary Outcome Measures

Outcome Measure
Lung function tests, peak expiratory flow rate, asthma symptoms & exacerbations, adverse events, sleep disturbance, rescue medication use, plasma cortisol (extension only).

Collaborators and Investigators

• Sponsor: Mundipharma Research Limited

Publications and helpful links

Helpful Links

• Results available on website

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): February 1, 2008
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: May 18, 2007
• First Submitted That Met QC Criteria: May 18, 2007
• First Posted (ESTIMATE): May 21, 2007

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Paediatric subjects with asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Xhance; Formoterol Fumarate
• Other Study ID Numbers: FLT3502; 2006-005928-16