Comparison of Flutiform, Fluticasone and Seretide in Treatment of Moderate to Severe Asthma in Paediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01511367
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : February 14, 2014
Information provided by (Responsible Party):
Mundipharma Research Limited

Brief Summary:
This is a comparator study to assess safety and efficacy of Flutiform compared with Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe persistent, reversible asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Flutiform Drug: Seretide Drug: Flixotide Phase 3

Detailed Description:
This is a study involving a 2-4 week run-in phase followed by a 12 week double blind treatment phase. During the run-in phase, all subjects receive Flixotide. In the treatment phase subjects will be randomised to one of the 3 treatment groups and will receive active Flutiform and placebo Flixotide or Active Seretide and placebo Flixotide or active Flixotide and either placebo seretide or placebo Flutiform. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, urinary cortisol and vital signs.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Double Dummy, Randomised, Parallel Group, Multicentre Study to Compare the Efficacy and Safety of Flutiform pMDI With Fluticasone pMDI and With Seretide pMDI in Paediatric Subjects Aged 5 to Less Than 12 Years With Moderate to Severe Persistent Reversible Asthma
Study Start Date : March 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Flutiform Drug: Flutiform
50/5ug (fluticasone/formoterol) 2 puffs twice daily

Active Comparator: Seretide Drug: Seretide
50/25 ug (fluticasone/salmeterol) 2 puffs twice daily

Active Comparator: Flixotide Drug: Flixotide
50ug 2 puffs twice daily

Primary Outcome Measures :
  1. To show superiority in the efficacy of Flutiform pMDI 50/5μg (2 puffs bid) versus fluticasone pMDI 50 μg (2 puffs bid). [ Time Frame: 12 weeks ]
    Change from pre-dose Forced Expiratory Volume in one second (FEV1) in litres at baseline to 2 hours post-dose FEV1 at the end of the 12 week treatment period.

Secondary Outcome Measures :
  1. Show non-inferiority in the efficacy of Flutiform to Seretide [ Time Frame: 12 weeks ]
    Change from pre-dose FEV1 at baseline to 2 hours post-dose FEV1 at Day 1 and FEV1 AUC0-4 at Day 1 and Week 12 (Flutiform vs Seretide)

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Male and Female subjects 5 to <12 years old.
  2. Known history of moderate to severe persistent reversible asthma1 for ≥ 6 months prior to the screening visit.
  3. Demonstrated FEV1 of ≥ 60% to ≤ 90% for predicted normal values (Polgar 1971) during the screening period following appropriate withholding of asthma medications (if applicable):

    • No LABA use within 12 hours and/or no SABA use within 6 hours of the PFT
    • No use of inhaled ICS-LABA asthma therapy within 12 hours of the PFT
    • Inhaled corticosteroids are allowed on the day of screening
  4. Documented reversibility of ≥ 15% in FEV1 in the screening period
  5. Current use of an inhaled corticosteroid for asthma at a stable dose for at least 4 weeks prior to the screening visit
  6. Inadequate asthma control on an ICS alone at a dose of ≤ 500 µg fluticasone equivalents/day, OR controlled asthma on an ICS-LABA combination at a ICS dose of ≤ 200 µg fluticasone equivalents/day
  7. Demonstrated satisfactory technique in the use of the pMDI and spacer device
  8. Can perform spirometry adequately
  9. Willing and able to enter information in the electronic diary with the help of a parent or guardian, if necessary and attend all study visits
  10. Willing and able to substitute pre-study prescribed inhaled asthma medication for the entire duration of the study
  11. If a female subject is post menarche a urine pregnancy test may be undertaken at the discretion of the investigator and the subjects' parent(s) /legal representative. This test must be negative.
  12. Written informed consent and assent obtained as per national law

Exclusion Criteria

  1. Near fatal or life-threatening (including intubation) asthma within the past year
  2. Hospitalisation or an emergency visit for asthma within the past 6 months
  3. History of systemic (injectable or oral) corticosteroid medication within 1 month of the screening visit
  4. Current or prior non-response or partial response only to an ICS-LABA combination1
  5. Evidence of a clinically unstable disease, as determined by medical history, clinical laboratory tests, and physical examination that, in the Investigator's opinion, preclude entry into the study. "Clinically significant" is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study
  6. In the Investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the screening visit
  7. Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiecstasis, tuberculosis)
  8. Known Human Immunodeficiency Virus (HIV)-positive status
  9. Current smoking history within 12 months prior to the screening visit
  10. Current evidence of alcohol or substance abuse within 12 months prior to the screening visit
  11. Subjects who have taken β- blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrythmics, or potent CYP 3A4 inhibitors such as ketoconazole within 1 week prior to the screening visit
  12. Current use of medications, other than those allowed in the protocol, that in the investigator's opinion will have an effect on bronchospasm and/or pulmonary function
  13. Current evidence of hypersensitivity or idiosyncratic reaction to test medications or components
  14. Receipt of an Investigational medicinal product within 30 days of the screening visit
  15. Current participation in a clinical study

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 identifier (NCT number): NCT01511367

Plovdiv, Bulgaria
Czech Republic
Alergologie Skopkova s.r.o
Ostrava-Marianske Hory, Czech Republic
Illés és Ádám Egészségügyi Szolgáltató Bt.
Kiskunhalas, Hungary
New Dehli, India
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp.z.o.o.
Tarnow, Poland
Spitalul Judetean de Urgenta Deva
Deva, Hunedoara, Romania
Russian Federation
Moscow, Russian Federation
Odessa, Ukraine
Sponsors and Collaborators
Mundipharma Research Limited

Responsible Party: Mundipharma Research Limited Identifier: NCT01511367     History of Changes
Other Study ID Numbers: FLT3506
2010-024635-16 ( EudraCT Number )
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014

Keywords provided by Mundipharma Research Limited:
moderate to severe persistent reversible asthma

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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
Hormones, Hormone Substitutes, and Hormone Antagonists