A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dā¦ (NCT05755906) | Clinical Trial Compass
CompletedPhase 3
A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS)
United States374 participantsStarted 2023-02-27
Plain-language summary
This is a 12-week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide metered dose inhaler in adults and adolescents with inadequately controlled asthma.
Who can participate
Age range12 Years ā 80 Years
SexALL
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Inclusion criteria
ā. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females of childbearing potential should be using highly effective birth control.
ā. Participants who have a documented history of physician-diagnosed asthma ā„ 6 months prior to Visit 1, according to GINA guidelines \[GINA 2021\]. Healthcare records for one year prior to Visit 1 must be provided for adolescent participants (12 to \< 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants.
ā. Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with allowed ICS doses, for at least 8 weeks prior to Visit 1.
ā. ACQ-7 total score ā„ 1.5 at Visits 1 and 4.
ā. A pre-bronchodilator/pre-dose FEV1 \< 90% predicted normal value at Visits 1, 2, and 3 and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization).
ā. Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ā„ 12% and ā„ 200 mL for participants ā„ 18 years of age OR a post-albuterol increase in FEV1 of ā„ 12% for participants 12 to \< 18 years of age either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3, if repeat testing is necessary.
ā. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that has not changed 20% or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit.
ā. Asthma stability during run-in based on Investigator discretion using the symptom worsening assessment defined in Section 8.1.2.8 as a guideline.
Exclusion criteria
What they're measuring
1
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0 to 3 Hours (AUC0-3) at Week 12
. Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).
ā. Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period.
ā. Hospitalization for asthma within 8 weeks of Visit 1.
ā. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
ā. Known history of drug or alcohol abuse within 12 months of Visit 1.
ā. Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1. Note: Squamous cell and basal cell carcinomas of the skin are not exclusionary.
ā. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in this protocol is prohibited for use during study duration.
ā. Previous or current randomization into studies within the AEROSPHERE program including KALOS, LOGOS, VATHOS, LITHOS, or any glycopyrronium studies (PT001).