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Comparison of Flutiform, fluticasone and Seretide in treatment of moderate to severe asthma in paediatric patients aged 5 to less than 12 years.

Conditions
Asthma Bronchiole
MedDRA version: 14.1Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Registration Number
EUCTR2010-024635-16-PL
Lead Sponsor
Mundipharma Research Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
498
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 laws

Are the trial subjects under 18? yes
Number of subjects for this age range: 498
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 ß- 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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: The primary objective of the study is to show superiority in the efficacy of Flutiform pMDI 50/5µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid).;Secondary Objective: The key secondary objective is to show non-inferiority in the efficacy of Flutiform 50/5 µg (2 puffs bid) to Seretide 50/25 µg (2 puffs bid)<br><br>Other secondary objectives of the study are to:<br>Compare the safety of Flutiform to fluticasone<br>Compare the safety of Flutiform to Seretide;Primary end point(s): Primary endpoint is the change from pre-dose FEV1 at baseline to 2 hours post-dose FEV1 over the 12 week treatment period.;Timepoint(s) of evaluation of this end point: End of the 12 week treatment period
Secondary Outcome Measures
NameTimeMethod
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