Mild to moderate asthma.
Conditions
Interventions
Product Name: Fluticasone-Salmeterol (Combination) HFA pMDI
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Fluticasone Propionate
CAS Number: 80474-14-2
Concentration uni
Sponsors
Neolab Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Either gender, aged 12-65 years. 2. Symptomatic with mild to moderate stable asthma defined by FEV1 =60% and =90% of that predicted by the European Community for Coal and Steel (ECCS) formulae. 3. Requirement for ICS but currently treated with =800 mg or equivalent of BDP per day. 4. Demonstrated reversibility of 15% in FEV1 15 minutes after inhalation of 400 mg salbutamol, unless reversibility has been documented within the previous 12 months. 5. Written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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. Daily requirement for >800 mg BDP, or equivalent. 2. Contraindication or known or suspected hypersensitivity to fluticasone propionate or salmeterol xinafoate or any other constituents of the investigational products. 3. Evidence of active concomitant pulmonary disease other than asthma. 4. Acute upper respiratory tract infection within 2 weeks of the screening visit. 5. Acute lower respiratory tract infections within 4 weeks of the screening visit. 6. Any change in asthma therapy (other than inhaled short-acting b2-agonists as rescue medication) or admission to hospital for treatment of asthma within 4 weeks preceding the screening visit. 7. More than 4 short courses of oral corticosteroids within the six months preceding the screening visit, or any oral corticosteroids in the preceding 4 weeks. 8. Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, haematological, neurological, immunological). 9. Clinically significant abnormal laboratory values. 10. Evidence of alcohol, drug or chemical abuse. 11. Women of child-bearing age who are unwilling to take adequate contraceptive precautions. 12. Pregnant or lactating women or women intending to become pregnant. 13. Treatment with any investigational drug or participation in another clinical trial within the 3 months preceding the screening visit. 14. Legal incapacity or other circumstances that render the patient unable to understand the nature, scope and possible consequences of the study. 15. In the investigator’s opinion, patients unlikely to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A new formulation of the combination of fluticasone propionate and salmeterol xinafoate in an HFA-propelled pMDI has been developed. This study aims to compare and demonstrate superiority of the effect of this combination with the effect of monotherapy with ICS on asthma management over two 4-week double-blind study periods. ;Secondary Objective: ;Primary end point(s): Primary Efficacy Endpoints: - Change from baseline trough FEV1 measured 12 hours after the last dose of each double-blind treatment. Secondary Efficacy Endpoints: - Mean morning PEF during Weeks 3 and 4 of each double-blind treatment compared with baselines. - Change from baseline in forced expiratory flow (FEF25-75) after each double-blind treatment - Symptom scores (diary data) - Use of rescue medication. - Global assessment of efficacy by investigator and patient Safety Endpoints: - Global assessment of tolerability by investigator and patient - The proportion of patients reporting cough, wheeze or breathlessness (i.e. rated as mild, moderate or severe) 15 minutes after the first inhalation of study medication - Vital signs. - Incidence of all adverse events. - Safety laboratory examination: haematology, biochemistry, and urinalysis. | — |
Countries
United Kingdom
Outcome results
None listed