Current Clinical Trials

Sneeze, Wheeze and Itch Associates, LLC

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Pediatric Asthma

  • Number
  • Type
  • Age Range
  • Length of Study
  • Compensation*
  • 30003
  • Pediatric Asthma
  • 4-11 yrs old
  • ~ 4 months
  • Up to $550

 

*Qualified participants may receive compensation for time and travel, up to the amount listed.

12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years With Persistent Asthma.

This study is to evaluate the safety and efficacy of Fluticasone Propionate and Fluticasone propionate Salmeterol in pediatric patients with a documented history of persistent asthma.

Inclusion Criteria:

  • The patient has a diagnosis of asthma as defined by the NIH
  • The patient has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for age, height, sex, and race at the screening visit (SV).
  • The patient’s persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV.
  • The patient (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device
  • The patient (with assistance from parents/legal guardians/caregivers, as needed) is able to use an MDI device and an MDPI device.
  • All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol at the SV for use as needed for the duration of the study
    • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The patient has a history of life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.
  • The patient is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the patient’s last study-related visit.
  • The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the IMP or rescue medication formulation (ie, lactose).
  • The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin) within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study.
  • The patient currently smokes or has a smoking history. The patient must not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
  • The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV or has had any hospitalization for asthma within 2 months before the SV.
  • The patient has used immunosuppressive medications within 30 days before the screening visit.
  • The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the run-in period.
  • The patient has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection.
  • The patient is an immediate relative of an employee of the clinical investigational center.
  • A member of the patient’s household is participating in the study at the same time
  • Vulnerable patients (ie, people kept in detention) are excluded from participation.
    • Additional criteria apply, please contact the investigator for more information

For more information, please call 309-452-0995 and ask to speak to a coordinator.