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AsthmaPhase 3IVIGNCT01992328

IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

A Phase 3 study testing Immune Globulin in people with Asthma, run by Ajou University School of Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Immunoglobulin G deficiency subtypes in patients with asthma six months once a month intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on reducing the frequency of asthma exacerbations appreciate. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Asthma
What is being tested?
Immune Globulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Dec 2013to Jan 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The patient from over 16 years to under 75 years
  • Patients diagnosed with asthma over six months ago
  • immunoglobulin G subtypes who were diagnosed with immune deficiency
  • more than 2 years Upper and lower respiratory tract infections
  • , and asthma exacerbations in this regard.
  • ① calculated creatinine clearance ≧ 50ml/min
Show all 9Show fewer
  • ALT and AST <x 3 times the upper limit of normal
  • ALP <x 3 times the upper limit of normal
  • total bilirubin <x 1.5 times the upper limit of normal

Who cannot join

  • within six months of the onset of the experiment who received immunoglobulin therapy
  • immune globulin for those with a history of hypersensitivity reactions
  • six months ago, another clinical trial participants.
  • Systemic steroids and immunomodulators, such as asthma control that may affect the resources required drug administration.
  • pregnant or lactating women.

About this study

Immunoglobulin G deficiency subtypes in patients with asthma six months once a month intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on reducing the frequency of asthma exacerbations appreciate.

Read the detailed description

Patients Registration

•It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.

Procedure

•six months once a month intravenous immunoglobulin (400mg/kg/4weeks)

Conditions
Asthma
Being tested
Immune Globulin
Keywords
Immunoglobulin G Deficiency
Medical subject headings
Asthma, IgG Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immune GlobulinDrug

    Also called Immunoglobulin G Deficiency

    6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)

Study groups in NCT01992328
Study groupRoleWhat they receive
Immune GlobulinExperimentalImmunoglobulin G Deficiency Associated with persistent asthma subtypes
Receives: Drug: Immune Globulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infection rate

    6 months after treatment compared to before treatment 6 months

    Measured: 6months

Secondary outcomes (9)

  1. lung funtion

    • Lung function (FEV1) compared

    Measured: 6 months

  2. steroid

    • Systemic steroid dose and the number of uses

    Measured: 6 months af

  3. antibiotic

    • The frequency and duration of antibiotic

    Measured: 6months

  4. asthma syptoms

    • The frequency of asthma exacerbations

    Measured: 6months

  5. Questionnaire

    • Asthma Quality of Life (AQOL)

    Measured: 6months

  6. Questionnair

    • Asthma control score (K-ACT)

    Measured: 6months

  7. IgG subclass

    • Before and after treatment serum IgG subclass

    Measured: 6months

  8. Cytokines

    • Cytokines serum levels before and after treatment

    Measured: 6months

  9. adverse events

    • The frequency of adverse events

    Measured: 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionJan 2017 (estimated)
  4. Study completionJan 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01992328
Sponsor's protocol ID
MED-CT4-12-405
Acronym
IVIG
Status last verified
Apr 2016
First submitted
11 Nov 2013
Last updated
2 May 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Immune Globulin in people with Asthma, run by Ajou University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infection rate (time frame: 6months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01992328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.

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