Brief title

Brief title chosen by the research group, intended for the lay public (can be omitted if the researchers wish)

Recruitment Status

Protocol accrual activity (Ongoing / Completed)

Protocol number

The unique trial number assigned to the protocol by the sponsoring organisation

Trial registration date

The date of inclusion in the Registry

Sponsor

Name of sponsoring organisation that takes responsibility for and initiates a clinical investigation

Official scientific title

Official name of the protocol provided by the study principal investigator or sponsor; this title must include the name of intervention, the condition being studied and the scope of the investigation

Condition

The medical condition (indication) being studied

Intervention

The generic name of Chiesi’s test product investigated.

Study type

Interventional/observational

Study design

Primary investigative techniques used in the protocol (type of allocation, type of masking, type of control and group assignment, duration)

Study phase

Phase of investigation: 1; 1-2; 2; 2-3; 3; 4 (post-marketing studies). Not applicable for observational trials

Brief summary

Short description of the primary purpose of the protocol intended for the lay public. Includes a brief statement of the study hypothesis

Primary outcome

The primary outcome that the study is designed to evaluate. Where applicable, description should include the time at which the outcome is measured

Key secondary outcomes

Key secondary outcomes specified in the protocol. Where applicable, description should include the time at which the outcome is measured

Key inclusion and exclusion criteria

Key patients characteristics that determine eligibility for participation in the study

Gender

Male/Female

Age limits

Minimum and maximum age of participants

Target number of subjects

The total number of subjects the investigators plan to enrol into the study according to protocol

Start date

First patient enrolment date (first visit)

Facility Locations

Name and addresses of the organisations where the trial is conducted

Research ethics review

Has the study at the time of registration received appropriate ethics committee approval (Yes/No)?

Research contact person

CTI (Clinical Trial Investigator) name and e-mail