Phase 3
Completed N=315
Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent Asthma
Source: ClinicalTrials.gov NCT01687283 ↗Enrolled (actual)
315
Serious AEs
1.9%
Results posted
Jun 2017
Primary outcomePrimary: Change From Baseline (Day 1 of Treatment Period/Visit 2) in Morning Peak Expiratory Flow (AM PEF) Over 12 Weeks in Intent-to-treat Population — 12.71; 14.51 Litres/Minute — p=0.733
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III local registration study for a treatment period of 12 weeks. This study aims to assess the effectiveness and safety of fluticasone propionate 1mg via nebulizer BID in treatment of Chinese adult and adolescent patients with severe persistent asthma for a treatment period of 12 weeks versus budesonide 2mg via nebulizer BID. The steady-state plasma pharmacokinetics of fluticasone propionate inhalation solution will also be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Day 1 of Treatment Period/Visit 2) in Morning Peak Expiratory Flow (AM PEF) Over 12 Weeks in Intent-to-treat Population |
12.71; 14.51 | 0.733 |
| PRIMARY Change From Baseline (Day 1 of Trt Period/Visit 2) in AM PEF Over 12 Weeks in Per Protocol Population |
13.50; 15.78 | 0.674 |
| SECONDARY Mean Change of Evening PEF From Baseline Over 12 Weeks |
12.39; 15.16 | 0.579 |
| SECONDARY Mean Change in Percentage of Symptom-free 24-hour Periods From Baseline Over 12 Weeks |
21.77; 21.15 | 0.854 |
| SECONDARY Median Day-time and Night-time Symptom Scores Per Participant Over 12 Weeks |
1.0; 1.0; 1.0; 1.0 | 0.123 |
| SECONDARY Mean Change in Percentage of Rescue-free 24-hour Periods From Baseline Over 12 Weeks |
19.27; 24.01 | 0.204 |
| SECONDARY Median Number of Times Rescue Medication Use Over 12 Weeks |
0.0; 0.0 | 0.170 |
| SECONDARY Change of Clinical Lung Function Measurement Forced Expiratory Volume in One Second (FEV1) From Baseline Over 12 Weeks |
0.122; 0.161; 0.187; 0.195; 0.175; 0.201 | 0.337 |
| SECONDARY Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution- Time to Maximum Observed Plasma Concentration (Tmax) |
0.905 | — |
| SECONDARY Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution-maximum Observed Plasma Concentration (Cmax) |
59.24 | — |
| SECONDARY Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution-area Under the Plasma Concentration-time Curve for the Dose Interval [AUC (0-τ)] |
403.0958 | — |
Eligibility Criteria
Inclusion Criteria
- Chinese male or female outpatients aged >=17 years and =12% and >=200mL reversibility of FEV1 within 15-30minutes following inhalation of 200-400ug of salbutamol aerosol within 12 months prior to visit 1 or at the Screening Visit.
- Subjects have pre-bronchodilator FEV1% predicted between >=40% and = 2 × upper limit of normal (ULN) or alkaline phosphatase (ALP) / bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin = 450 msec or >= 480 msec for patients with bundle branch block at the time of screening.
- A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub Investigator, study coordinator, or employee of the participating Investigator.
- No subject is permitted to perform night shift work from Visit 1 until completion of the study treatment period.
- Use of the following medications within the following time intervals prior to visit 1 or during the study: Medication / No use within the following time intervals prior to Screening (Visit 1) or at any time during the study Systemic or oral corticosteroids / 2 weeks Depot corticosteroids /12 weeks Anti-IgE (e.g. Xolair)/ 12 weeks Oral long-acting beta2-agonists (e.g. bambuterol) and inhaled long-acting beta2-agonists (e.g. salmeterol, formoterol) or combination products containing inhaled long-acting beta2-agonists (e.g. Seretide, Symbicort) / 12 hours (the stable dose of ICS/LABA combination within 2 weeks prior to Visit 1 could be continued during the run-in period) Theophyllines, slow-release bronchodilators, anticholinergics, ketotifen, nedocromil sodium, sodium cromoglycate, Anti-leukotrienes including suppressors of leukotriene production and antagonists / 1 day Inhaled short-acting beta2-agonist / 4 hours (salbutamol will be supplied for rescue during the study) Potent Cytochrome P450 3A4 inhibitors(e.g. ritonavir, ketoconazole, itraconzole) / 4 weeks Prescription or over the counter medication that would significantly affect the course of asthma, or interact with sympathomimetic amines, such as: anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants; beta-adrenergic blocking agents; phenothiazines and monoamine oxidase (MAO) inhibitors /1 day Chinese traditional medicines used for treatment of asthma and other allergic diseases / 1 week Any other investigational drug / 30 days or within 5 half lives, whichever is longer
Data sourced from ClinicalTrials.gov (NCT01687283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.