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Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure (ALPHO)

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ClinicalTrials.gov Identifier: NCT02250729
Recruitment Status : Recruiting
First Posted : September 26, 2014
Last Update Posted : December 27, 2018
Sponsor:
Collaborators:
Zambon SpA
Laboratoires URGO
THE BOOTS COMPANY PLC
Pierre Fabre Medicament
LABORATOIRE HEPATOUM
Biocodex
Sanofi
Laboratoires Bouchara-Recordati
GlaxoSmithKline
ALLIANCE PHARMACEUTICALS LIMITED
BELL SONS & COMPANY
PINEWOOD LABORATORIES LIMITED
THORNTON & ROSS & Ross Ltd
ERNEST JACKSON & Co. Ltd
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

The main objective of this study is to compare pholcodine exposure in patients having presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine exposure in matched anaesthetised patients with injection of NMBA, who did not present with an anaphylactic reaction (controls).

The secondary objectives of the study are:

  • To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.
  • To study the concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.
  • To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.
  • To study the association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.
  • To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to (at least) one NMBA.

Condition or disease Intervention/treatment Phase
Neuromuscular Blocking Agents Anaphylaxis Other: intradermal pholcodine allergy test in cases Other: Blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study
Actual Study Start Date : July 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anaphylaxis

Arm Intervention/treatment
Experimental: cases with NMBA anaphylaxis
Patients who experienced NMBA anaphylaxis during anesthesia
Other: intradermal pholcodine allergy test in cases
Other: Blood sampling
controls
Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis
Other: Blood sampling



Primary Outcome Measures :
  1. Exposure to pholcodine [ Time Frame: within the 12 months before the anesthetic procedure ]
    Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's


Secondary Outcome Measures :
  1. Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups. [ Time Frame: Between 1 day to 12 weeks after the general anesthetic procedure ]
    Cases: 6 to 12 weeks after the general anesthetic procedure (corresponding to the day of inclusion) Controls: during their hospitalisation after the general anesthetic procedure (Maximum 90 days after the general anesthetic procedure, corresponding to the day of inclusion)

  2. Concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file. [ Time Frame: within the 12 months preceeding the general anesthesia ]
  3. Impact of non subjective sources in pholcodine exposure assessment [ Time Frame: within the 12 months preceeding general anesthetic procedure ]
    We will study if pholcodine exposure criteria measured by autoquestionnaire is modified by taking into account non subjectives sources which are the patient's pharmaceutical file and his drug history by his pharmacist's

  4. Association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine. [ Time Frame: within the 12 months preceding the general anesthetic procedure ]
    IgE measurements: total IgE, IgE specific for pholcodine, quaternary ammoniums (KU/L)

  5. NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to one NMBA. [ Time Frame: 6 to 12 weeks after the general anesthetic procedure ]

    Only for Cases :

    Intradermal tests with diluted pholcodine. Intradermal tests with diluted NMBAs (as usual)




Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age ≥ 2 years old.
  • Referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of occurrence of peranaesthetic anaphylactic reaction during anaesthesia with administration of NMBAs (only for case patient).
  • Having given his/her consent (or the 2 parents consent for minors).
  • Affiliated with a social security scheme or dependent.
  • Able to answer a medicinal product intake questionnaire
  • In a clinical condition compatible with skin tests (no skin disease or psychiatric illness, etc.) (only for case patient)
  • Having stopped any anti-histamine treatment at least 8 days previously (only for case patient).
  • With positive skin test for the suspected NMBA (ony for case patient).
  • Patient anaesthetised in a control recruitment centre (only for control patients)
  • Having undergone anaesthesia with NMBA injection, without onset of peranaesthetic anaphylactic reaction whatever his medical history (only for control patients)

Exclusion Criteria:

  • Patients who have refused, or are unable to give their consent
  • Patients who have had negative control skin tests
  • Anaphylaxis suspected to be related to other drugs given on induction of anaesthesia, eg. antibiotics
  • Having presented with anaphylactic reaction during a previous anaesthesia without NMBA injection
  • Pregnant females at inclusion or during 12 months before anaesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250729


Contacts
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Contact: Pierre Gillet, MD PhD pierre.gillet@univ.lorraine.fr

Locations
Show Show 24 study locations
Sponsors and Collaborators
Central Hospital, Nancy, France
Zambon SpA
Laboratoires URGO
THE BOOTS COMPANY PLC
Pierre Fabre Medicament
LABORATOIRE HEPATOUM
Biocodex
Sanofi
Laboratoires Bouchara-Recordati
GlaxoSmithKline
ALLIANCE PHARMACEUTICALS LIMITED
BELL SONS & COMPANY
PINEWOOD LABORATORIES LIMITED
THORNTON & ROSS & Ross Ltd
ERNEST JACKSON & Co. Ltd
Investigators
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Principal Investigator: Pierre GILLET, PU-PH MD CHU de Nancy
Study Director: Paul-Michel MERTES, PU-PH MD CHU de Strasbourg
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02250729    
Other Study ID Numbers: 2012-A01735-38
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Keywords provided by Central Hospital, Nancy, France:
anaphylaxis
pholcodine
neuromuscular blocking agents
Additional relevant MeSH terms:
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Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pholcodine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antitussive Agents
Respiratory System Agents