Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT06201728
Brief Summary:
The goal of this interventional study is to examine the effect of asthma flare-up clinic follow-up in adult subjects after an asthma flare-up. This study aim to answer the following questions:
1. Does a follow-up in a flare-up clinic improves disease outcomes?
2. Does a follow-up in a flare-up clinic improves disease management?
Participants in the intervention group will take part in a structured follow-up at the asthma flare-up clinic at three time points. Each visit will include questionnaires, pulmonologist examination and consultation, laboratory tests and spirometry. The control group will undergo phone-call follow-up with a research coordinator in similar time frames as the intervention.
Researchers will compare the two groups to see if the clinic follow-up affects the study outcomes.
Detailed Description:
The primary outcomes will be analyzed as total exacerbations during the time frame and as a time-dependent variable (time to exacerbation) using Kaplan Meier survival analysis. Additional sub-analyses will be made for the type of inclusion setting (ED/hospitalization), number of prior exacerbations, and eosinophil count. Additional analyses will be made for all secondary outcomes. Analyses relevant only for the intervention group (such as spirometry and IOS) will compare results to the first follow-up visit. A cost-effectiveness analysis will be made, comparing the follow-up cost and the cost saved by exacerbation reduction based on the final results.
Sample size calculation - The invetigators assume based on previous research that the intervention will lead to a 20% decrease in exacerbations during the 12 months from first follow-up. To achieve an alpha of 0.05 and a power of 80%, there is a need for 88 patients in each group. Assuming a loss-to-follow-up rate (missing to complete at least 2 clinic visits or loss to phone follow-up) of 20%, the study will need 115 patients in each group (230 overall).
Study:
NCT06201728
Study Brief:
Protocol Section:
NCT06201728