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Tests treatment safety and results for Asthma
Official title A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
ClinicalTrials.gov ID: NCT06664619
What this study is testing
What is Fp/ABS?
Fp/ABS is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for asthma.
Also referred to as fluticasone propionate/albuterol sulfate combination.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI). Secondary objectives are: To evaluate the efficacy of Fp/ABS eMDPI administered four times daily To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- The participant has a diagnosis of asthma of at least 6 months duration.
- Participants currently receive a beta-agonist (eg, salbutamol [albuterol] or ICS albuterol or ICS-formoterol) as rescue medication with or without...
- If female, a participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit...
You likely can't join if
- The participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated...
- The participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of COVID-19 within 6 weeks prior to...
- The participant is a current smoker and/or has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has...
- The participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Encinitas, California, United States
- Huntington Beach, California, United States
- La Palma, California, United States
- Laguna Niguel, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Oxnard, California, United States
- Sacramento, California, United States
- San Jose, California, United States
- Upland, California, United States
- Vista, California, United States
- Walnut Creek, California, United States
- Lakewood, Colorado, United States
- Lake City, Florida, United States
- Lake Worth, Florida, United States
- Melbourne, Florida, United States
+ 127 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Encinitas, California, United States; Huntington Beach, California, United States; La Palma, California, United States and 141 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.