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Azithromycin for treatment of hospitalized children with asthmatic symptoms - A double-blind, randomized, controlled study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512605-29-01
Acronym
COPSACazt
Enrollment
320
Registered
2024-06-14
Start date
2024-07-01
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood asthma

Brief summary

Duration (in days) of the asthma-like episode from the start of randomization.

Detailed description

1) Change in symptom score from day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years assessed using a previously validated symptom scoring model based on a diary., 2) The length of hospitalization., 3) Need for SABA during the asthma-like episode., 4) Need for oral corticosteroids (OCS) during the asthma-like episode., 5) Stratification of the above analyzes on the basis of the presence or absence of bacteria in the airways., 6) Percentage of days away from daycare offers and / or work for parents / guardians., 7) Assessment of the health economic gain based on treatment costs and lost earnings for parent / guardian (s).

Interventions

DRUGBANANA FLAVOUR
DRUGXANTHUM GUM
DRUGSUCROSE
DRUGPlease see attached files
DRUGHYDROXYPROPYL CELLULOSE LF
DRUGAZITHROMYCIN
DRUGSODIUM PHOSPHATE DODECAHYDRATE

Sponsors

Herlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Duration (in days) of the asthma-like episode from the start of randomization.

Secondary

MeasureTime frame
1) Change in symptom score from day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years assessed using a previously validated symptom scoring model based on a diary., 2) The length of hospitalization., 3) Need for SABA during the asthma-like episode., 4) Need for oral corticosteroids (OCS) during the asthma-like episode., 5) Stratification of the above analyzes on the basis of the presence or absence of bacteria in the airways., 6) Percentage of days away from daycare offers and / or work for parents / guardians., 7) Assessment of the health economic gain based on treatment costs and lost earnings for parent / guardian (s).

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026