Mild persistent asthma MedDRA version: 16.1 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 100000004855
Conditions
Interventions
Trade Name: flutiform
Product Name: flutiform pMDI 50ug/5ug
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Fluticasone propionate
CAS Number: 80474-14-2
Other descriptiv
Sponsors
Mundipharma Research Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and Female subjects 5 to 2 weeks prior to the screening visit. 7.Demonstrates adequate spirometry technique and able to use a home PEFR meter. 8.Demonstrated FEV1 of = 80% predicted value at visit 1following appropriate withholding of asthma medications (if applicable) (no SABA use within 6 hours of the PFT). 9.Demonstrated satisfactory technique in the use of the pMDI plus spacer and Autohaler devices. 10.Must be continent of urine and willing to perform (with parental/guardian help) overnight urine collections. 11.Willing and able to complete morning and evening PEFR measures with the help of a parent or guardian, if necessary, and attend all study visits. 12.Willing and able to substitute pre-study prescribed inhaled asthma medication for the entire duration of the study with study medication. 13.Written informed consent obtained as per national laws. Inclusion Criteria required following run-in: 14.FEV1 within =20% of the visit 1 value following appropriate withholding of rescue medication (no Airomir Autohaler use within 6 hours of the PFT). 15.Rescue medication use on =2 days during the last 7 days of the run in period. Are the trial subjects under 18? yes Number of subjects for this age range: 48 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
Exclusion criteria: 1.Require medications other than inhaled SABAs and/or regular non-ICS controller medications (e.g., cromones or leukotriene receptor antagonists) to maintain asthma control. 2.ICS use within = 2 weeks prior to the screening visit. 3.Any asthma exacerbation of any severity for at least 3 months prior to the screening visit. 4.Any fracture in the leg to be measured by knemometry =6 months prior to the screening visit. 5.Any metabolic disorders or other diseases that may impact on normal growth patterns. 6.Near fatal or life-threatening asthma within the past year. 7.Hospitalisation or an emergency visit for asthma within the past 6 months. 8.History of oral or injectable corticosteroid medication =3 months prior to the screening visit. 9.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. 10.No major surgery requiring general anesthesia for at least 3 months prior to the screening visit. 11.No febrile illnesses with temperature > 39°C within a week of the screening visit. 12.In the Investigator’s opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the screening visit. 13.Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis). 14.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. 15.Current use of medications, other than those allowed in the protocol. 16.Current evidence of hypersensitivity or idiosyncratic reaction to test medications or components. 17.Receipt of an Investigational medicinal product within 30 days of the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.;Secondary Objective: Secondary Objectives: •To compare the safety of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on overnight urinary free cortisol (corrected for creatinine). Exploratory Objectives: •To compare mean lower leg growth rates with flutiform pMDI 50/5 µg and fluticasone pMDI 50 µg versus beclometasone Autohaler 50 µg. •To compare the safety of flutiForm pMDI 50/5 µg and fluticasone pMDI 50 µg to beclometasone Autohaler 50 µg based on overnight urinary free cortisol (corrected for creatinine). •To compare the efficacy of flutiForm pMDI 50/5 µg, fluticasone pMDI 50 µg and beclometasone Autohaler 50 µg by means of FEV1, PEFR, rescue medication use, asthma exacerbations asthma symptoms and activity limitations. ;Primary end point(s): Mean lower leg growth rate during each period ;Timepoint(s) of evaluation of this end point: Subjects randomised to receive one 1 of 3 possible treatment sequences outlined below:- 1)Treatment A:-Flutiform 50/5ug(2 puffs bid) pMDI 2)Treatment B:-Fluticasone 50ug(2 puffs bid) pMDI 3)Treatment C:-Beclometasone 50ug(2 puff bid) Each Treatment Phase is 14 days, separated by 14 days for the wash-out period. Measurement of lower leg growth using the knemometer will be taken at each visit by an assessor who is blinded to the study treatment. Knemometry measurements at visits 1 to 7 taken at the same time (+/-1hour) on the same day of the week wherever possible, corresponding to the beginning and the end of each treatment or wash-out period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Mean 12-hour urinary free cortisol (corrected for creatinine) during each period. •Spontaneously reported adverse events. •Mean FEV1 at clinic visits. •Mean daily PEFR during each period. •Days of rescue medication use during each period. •Number (%) of asthma exacerbations during each period. •Number (%) of asthma symptoms during each period. •Number % of subjects who experienced any activity limitation due to asthma during each period. •Study medication use (compliance) during treatment period. ;Timepoint(s) of evaluation of this end point: •12-hour urinary free cortisol (corrected for creatinine) during each period - overnight urine collections at end of each treatment phase. •Spontaneously reported adverse events collected at during of study •FEV1 at clinic visits. •Daily PEFR during each period - morning & evening •Days of rescue medication use during each period. •Number (%) of asthma exacerbations during each period - day and evening •Number (%) of asthma symptoms during each period. •Number % of subjects who experienced any activity limitation due to asthma during each period. •Study medication use (compliance) during treatment period. Refer to protocol for full details | — |
Countries
Denmark
Contacts
Public ContactEuropean Medical Operations
Mundipharma Research Ltd
Outcome results
None listed