Persistent asthma and seasonal allergic rhinitis. MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma MedDRA version: 9.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Interventions
Trade Name: Fluticasone Propionate Aqeous Nasal Spray 200mcg
Product Name: Flixonase Aqueous Nasal Spray
Product Code: CCI18781
Pharmaceutical Form: Nasal spray, solution
Pharmaceutical form of the pl
Sponsors
GlaxoSmithKline R&D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be considered eligible for inclusion in this study only if all of the following criteria apply: 1. Consent: A signed and dated written informed consent must be obtained from the subject or subject’s legally acceptable representative prior to study participation. An informed consent must be signed prior to any change in the subject’s medication regimen, including withholding medications prior to Visit 1. 2. Gender: Male or female. Females are eligible to participate only if they are currently not pregnant and not lactating. Females of child-bearing potential will be required to use a highly effective method for avoiding pregnancy (i.e., contraception with a failure rate of =65 years
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Currently Diagnosed with Life-Threatening Asthma: An episode or episodes of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures. 2. Asthma Instability: Hospitalization for asthma within 6 months of Visit 1. 3. Concurrent Respiratory Disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, or any other respiratory abnormalities other than asthma. 4. Nasal Obstruction: Severe physical obstruction of the nose (e.g., deviated septum) that could affect the deposition of double-blind intranasal study drug. 5. The list of additional excluded conditions/diseases includes, but is not limited to: cardiac arrhythmias; congestive heart failure; coronary artery disease; poorly controlled diabetes, poorly controlled hypertension, poorly controlled peptic ulcer, hematologic, hepatic, or renal disease; immunologic compromise; current malignancy; current or quiescent tuberculosis, and Cushing’s or Addison’s disease. 6. Respiratory Tract Infections: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 14 days immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 14 days prior to Visit 1. 7. Concurrent Medications: Concurrent use of any of the following medications that may affect the course of asthma, rhinitis, or interact with sympathomimetic amines or montelukast. • Beta-blockers • tricyclic antidepressants • monoamine oxidase inhibitors • phenobarbital • rifampin • ritonavir • ketoconazole 8. Systemic Corticosteroids: Use of oral or parenteral systemic corticosteroids within 28 days of Visit 1, or requirement for more than two courses of parenteral systemic corticosteroids for asthma within 6 months of Visit 1. NOTE: Topical hydrocortisone cream or ointment (1% or less) is permitted during the study. 9. Excluded Rhinitis Medications: rhinitis medications ( as excluded in the protocol) must be withheld during the corresponding “exclusion period” prior to Visit 1 and are not allowed any time during the study, unless dispensed as double-blind study drug. 10. Excluded Asthma Medications: asthma medications must be withheld during the corresponding “exclusion period” prior to Visit 1 ( as specified in the protocol). These asthma medications, with the exception of an inhaled corticosteroid/long-acting beta2-agonist combination product and Xolair, may be continued during the run-in period of the study (between Visits 1 and 2), but must be withheld prior to Visit 2 for the appropriate “exclusion period”. These asthma medications are not allowed any time after randomization at Visit 2 (with the exception of as as-needed rescue albuterol/salbutamol), unless dispensed as double-blind study drug ( see specifics in Protocol): Inhaled corticosteroid/long-acting beta2-agonist combination product (e.g., ADVAIR) Inhaled anticholinergics (e.g., Atrovent, Combivent, Spiriva) Theophylline products Inhaled cromolyn or nedocromil Inhaled corticosteroids Long-acting beta2-agonists (e.g., Foradil, SEREVENT™) Oral beta2-agonists
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study are to show that fluticasone propionate/salmeterol combination product 100/50mcg (FSC) BID (available as Seretide DISKUS) is superior to montelukast 10mg OD (available as Singulair) as monotherapy for asthma, and that Montelukast administered concurrently with FSC adds no additional benefit to FSC alone in improving asthma control in a population of subjects with allergic asthma. ;Secondary Objective: To show that in the presence of FSC, fluticasone propionate aqueous nasal spray 200mcg (FPANS) OD (available as FLIXONASE) is superior to Montelukast for control of rhinitis symptoms in this population.;Primary end point(s): The primary efficacy measures are the mean change from baseline at endpoint in morning Peak Expiratory Flow (PEF) compared between the fluticasone propionate/salmeterol combination product 100/50mcg BID (FSC) and montelukast 10mg OD (MON) treatment groups to assess superiority and compared between the FSC and FSC+Montelukast treatment groups to assess equivalence. | — |
Countries
Estonia, Finland
Outcome results
None listed