Trial document




drksid header

  DRKS00006171

Trial Description

start of 1:1-Block title

Title

Questionaire based study concerning airplane travel in patients with lymphangioleiomyomatosis (LAM)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

LAM and travel

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

questionaire based study concerning airplane travel (frequency, duration, complications or avoidance) of patients with lymphangioleiomyomatosis (LAM). Patients will be provided with a self- made questionaire and this questionaire will be analysed in the context of the study.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Patients with lymphangioleiomyomatosis have an increased risk for pneumothoraces. Until today there are no general guidelines for phycicians to answer patients request how to handle airplane travel. Many physicians advise their patients not to travel by airplane. We know from many patients that - despite the advise patients often travel by airplane. This study should collect the experiance of the patients with air travel.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006171
  •   2014/06/24
  •   [---]*
  •   yes
  •   Approved
  •   043/14, Ethikkommission der Ärztekammer Schleswig-Holstein (Ethik-Kommission I)
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   LAM (Lymphangioleiomyomatosis)
  •   D48 -  Neoplasm of uncertain or unknown behaviour of other and unspecified sites
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   questionaire based study concerning airplane travel (frequency, duration, complications or avoidance) of patients with lymphangioleiomyomatosis (LAM). Patients will be provided with a self- made questionaire and this questionaire will be analysed in the context of the study.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

description of status quo in patients with LAM (lymphangioleiomyomatosis) and data to airtravel

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/11/10
  •   30
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

diagnosis of lymphangioleiomyomatosis

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

not applicable

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf
    • Woehrendamm 80
    • 22927  Grosshansdorf
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Pneumologsches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
    • Ms.  Dr.  Anne-Marie  Kirsten 
    • Wöhrendamm 80
    • 22927  Großhansdorf
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf
    • Ms.  Dr. med.  Anne-Marie  Kirsten 
    • Woehrendamm 80
    • 22927  Grosshansdorf
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf
    • Woehrendamm 80
    • 22927  Grosshansdorf
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/11/10
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.