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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited
ClinicalTrials.gov Identifier:
NCT01511367
First received: December 7, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Asthma
Drug: Flutiform
Drug: Seretide
Drug: Flixotide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mundipharma Research Limited:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Show non-inferiority in the efficacy of Flutiform to Seretide [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 498
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01511367

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

No publications provided

Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT01511367     History of Changes
Other Study ID Numbers: FLT3506, 2010-024635-16
Study First Received: December 7, 2011
Last Updated: February 13, 2014
Health Authority: Hungary: National Institute of Pharmacy

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 16, 2014