A open-label, multicentre study to monitor the safety of inhaled zanamivir (as Rotadisk via Diskhaler device) in China.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TNRC-10000938

Enrollment

Unknown

Registered

2010-07-03

Start date

2010-03-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Influenza

Interventions

Group A:Zanamivir

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects'age equals or more than 12y; 2. Subjects with the approved indication in the Relenza (Zanamivir as Rotadisk via Diskhaler device) Chinese prescribing information; 3. Subjects administrated Relenza (Zanamivir as Rotadisk via Diskhaler device) at the discretion of the investigator (e.g. patients with influenza like illness); 4. Subjects with no contraindication according to the Chinese prescribing information; 5. Subjects who are willing and able to give written informed consent to participate in the study (if the subjects are below the legal age of consent, the legally acceptable representative also provides consent).

Exclusion criteria

Exclusion criteria: 1. Subjects who are known or suspected to be hypersensitive to any component of the study medication; 2. Subjects who have received any influenza antiviral therapy in the previous seven days, e.g. rimantadine, amantadine, or oseltamivir.

Design outcomes

Primary

Measure	Time frame
SAE;	—

Secondary

Measure	Time frame
Unexpected SAE,SAE;Effectiveness of ZAN;AE;	—

Countries

China

Contacts

Public ContactChen Wang

cyh-birm@263.com+86 10 85231167

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026