Real-World Effectiveness of Tezepelumab in Allergic Bronchopulmonary Aspergillosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQianfoshan Hospital
About this trial
An open-label study will evaluate effects of Tezepelumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Tezepelumab
Drug210 mg (1.91 mL) Subcutaneous Solution
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Experimental: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of steroid requiring exacerbations
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA
Time frame
26 weeksSecondary outcomes
1
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire
The change from baseline score in Saint George Respiratory Questionnaire. The Saint George Respiratory Questionnaire (SGRQ) total score ranges from 0 to 100. Higher scores indicate a worse outcome (greater health impairment/poorer quality of life)
Time frame
26 weeks2
Asthma Control as assessed by Asthma Control Questionnaire 6
The change from baseline score in Asthma Control Questionnaire 6. ACQ-6 scores range from 0 to 6, where higher scores represent poorer asthma control. A score ≤0.75 indicates well-controlled asthma, while a score ≥1.5 indicates uncontrolled asthma.
Time frame
26 weeks3
Lung Function (FEV1)
The FEV1 change from baseline to End of Treatment
Time frame
26 weeksSponsors and contacts
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Source ClinicalTrials.gov
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