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

NCT01511367 | Completed Phase 3

• 2 other identifiers: FLT35062010-024635-16
• Study Type: interventional
• Target: 498
• Locations: 8 countries
• Sites: 8

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.

Conditions

Asthma

Keywords

moderate to severe persistent reversible asthma

Outcome Measures

Primary Outcomes (1)

• To show superiority in the efficacy of Flutiform pMDI 50/5μg (2 puffs bid) versus fluticasone pMDI 50 μg (2 puffs bid).

  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.

  12 weeks

Secondary Outcomes (1)

• Show non-inferiority in the efficacy of Flutiform to Seretide

  12 weeks

Study Arms (3)

Flutiform

ACTIVE COMPARATOR

Drug: Flutiform

Seretide

ACTIVE COMPARATOR

Drug: Seretide

Flixotide

ACTIVE COMPARATOR

Drug: Flixotide

Interventions

Flutiform DRUG

50/5ug (fluticasone/formoterol) 2 puffs twice daily

Flutiform

Seretide DRUG

50/25 ug (fluticasone/salmeterol) 2 puffs twice daily

Seretide

Flixotide DRUG

50ug 2 puffs twice daily

Flixotide

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and Female subjects 5 to \<12 years old.
• Known history of moderate to severe persistent reversible asthma1 for ≥ 6 months prior to the screening visit.
• 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
• Documented reversibility of ≥ 15% in FEV1 in the screening period
• Current use of an inhaled corticosteroid for asthma at a stable dose for at least 4 weeks prior to the screening visit
• 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
• Demonstrated satisfactory technique in the use of the pMDI and spacer device
• Can perform spirometry adequately
• 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
• Willing and able to substitute pre-study prescribed inhaled asthma medication for the entire duration of the study
• 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.
• Written informed consent and assent obtained as per national law

You may not qualify if:

• Near fatal or life-threatening (including intubation) asthma within the past year
• Hospitalisation or an emergency visit for asthma within the past 6 months
• History of systemic (injectable or oral) corticosteroid medication within 1 month of the screening visit
• Current or prior non-response or partial response only to an ICS-LABA combination1
• 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
• In the Investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the screening visit
• Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiecstasis, tuberculosis)
• Known Human Immunodeficiency Virus (HIV)-positive status
• Current smoking history within 12 months prior to the screening visit
• Current evidence of alcohol or substance abuse within 12 months prior to the screening visit
• 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
• 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
• Current evidence of hypersensitivity or idiosyncratic reaction to test medications or components
• Receipt of an Investigational medicinal product within 30 days of the screening visit
• Current participation in a clinical study

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (8)

Unknown Facility

Plovdiv, Bulgaria

Location

Alergologie Skopkova s.r.o

Ostrava-Marianske Hory, Czechia

Location

Illés és Ádám Egészségügyi Szolgáltató Bt.

Kiskunhalas, Hungary

Location

Unknown Facility

New Dehli, India

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp.z.o.o.

Tarnów, Poland

Location

Spitalul Judetean de Urgenta Deva

Deva, Hunedoara, Romania

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Odesa, Ukraine

Location

Related Links

• Link to Results

MeSH Terms

Conditions

Asthma

Interventions

fluticasone-formoterol; Fluticasone-Salmeterol Drug Combination; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: January 18, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

UA (1); PL (1); RU (1); RO (1); CZ (1); IN (1); HU (1); BU (1)