Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization Wit… (NCT06563102) | Clinical Trial Compass
CompletedPhase 4
Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma
United States101 participantsStarted 2024-09-11
Plain-language summary
The purpose of this study is to compare the efficacy and safety of albuterol/budesonide to albuterol in changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma.
Study details include:
* The study duration will be up to 15 weeks.
* The treatment duration will be 12 weeks.
* The visit frequency will be once every 4 weeks, with 3 clinic visits and 2 video calls in total.
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion criteria
✓. Symptoms requiring rescue medication use for a minimum of 2 days per week for the last 14 days during the Lead-in Period (minimum 4 uses total)
✓. At least 80% overall compliance rate for performing daily FeNO and spirometry assessments and completing the twice-daily asthma symptom and rescue medication use diary during the Lead-in Period.
Exclusion criteria
✕. Any significant disease or disorder, or evidence of drug/substance abuse which in the investigator's opinion would pose a risk to participant safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the participant to participate in the study.
✕. Medical history of life-threatening asthma including intubation and intensive care unit admission.
✕. Medical conditions (other than allergic rhinitis) or medications that will influence FeNO, as judged by the investigator.
✕. Concurrent respiratory disease: presence of a known pre-existing, clinically important lung condition other than asthma (eg, cystic fibrosis, idiopathic pulmonary fibrosis, pulmonary arterial hypertension, chronic obstructive pulmonary disease).
✕. Any disease state or procedure that is likely to necessitate the use of oral/systemic corticosteroids during the Treatment Period, other than asthma.
✕. Malignancy: a current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (participants with treated localized squamous cell or basal cell carcinoma of the skin will not be excluded, whereas participants who had melanoma will be excluded). Participants with a history/treatment of malignancy, and which in the investigator's opinion could compromise the safety of the participant.
What they're measuring
1
Change from baseline to maximum value of daily morning FeNO
✕. Other concurrent medical conditions: participants who have known, pre-existing, clinically significant cardiovascular (including clinically significant cardiac arrhythmia and participants with known QT interval corrected for heart rate using the Fridericia formula \> 480 ms), endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
✕. Current smokers: previous smokers are allowed to be included provided that they stopped smoking \> 12 months prior to Visit 1 AND have a smoking history of ≤ 10 pack-years (includes tobacco, e-cigarettes, vapes, marijuana, etc.).