Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent As… (NCT01687283) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent Asthma
China316 participantsStarted 2012-09-27
Plain-language 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.
Who can participate
Age range
17 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Chinese male or female outpatients aged \>=17 years and \<=70 years
* A female is eligible to enter and participate in this study if she is:
Non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchal, post-menopausal), or Child-bearing potential, has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) (referring to appendix 1: Highly Effective Methods For Avoidance Of Pregnancy In Women Of Childbearing Potential) which, in the opinion of the investigator are adequate to prevent pregnancy during the study.
* A documented clinical history of asthma for a period of at least 12 weeks prior to Visit 1 based on the Guidance of Asthma Management and Prevention 2008 in China (refer to appendix 2).
* Demonstrated \>=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 \<80% at visit 1.
* Subjects on a stable dose at least 2 weeks with high dose ICS (eg. Fluticasone Propionate 500ug twice daily or other ICS with equivalence doses, refer to Appendix 3) or moderate dose ICS plus LABA (eg. Fluticasone Propionate/Salmoterol 250/50ug , twice daily; or Budesonide/Formoterol Fumarate in maintainance160/4.5ug, two inhalation, twice daily; or other product…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Baseline (Visit 2) and up to Week 12
2
Change From Baseline (Day 1 of Trt Period/Visit 2) in AM PEF Over 12 Weeks in Per Protocol Population