Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901529431463 Date of Approval: 15/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating Sublingual immunotherapy in allergic Rhinoconjunctivitis
Official scientific title Evaluation of the Efficacy and Safety of Sublingual Immunotherapy ( Traditional Coca’s extract) in the treatment of Allergic Rhinoconjunctivitis
Brief summary describing the background and objectives of the trial Allergic rhinitis is a widely spread disease affects 10-40 % of the population. It is an allergic disorder affects the mucosa of nose, sinuses and sometimes conjunctiva. It is associated with conjunctivitis in 30%–70% of patients, so it is more appropriately known as allergic rhino-conjunctivitis, in most cases patients suffers from symptoms that impair the quality of life, these may include: nasal congestion, headache, post nasal discharges, itchy/a runny nose in addition to red, congested watery and itchy eyes. Furthermore, symptoms may extend to affect the ears and mucosa of the pharynx.1,2 Uncontrolled allergic rhino-conjunctivitis may also aggravate the symptoms of asthma.3 Although antihistamines, anti-, and corticosteroids form the primary line of pharmacological treatment for allergic rhinitis, they are all considered as a symptomatic treatment that does not affect the principle immunological mechanism that develops the allergic condition. Meanwhile, allergen-specific immunotherapy is known to modify the underlining immunopathological process.4 Allergen-specific immunotherapy is administered either through subcutaneous or sublingual route. Although different regimens are available, the principle of treatment includes two significant phases: build-up phase in which the patient is given increasing amount of allergen extract and maintenance phase during which fixed doses of the highest concentration are given to the patient. The overall duration ranges from three to five years.4,5 Sublingual immunotherapy is as effective as subcutaneous immunotherapy. Also, it is painless, safer and thus more convenient for patients especially, if the long duration of treatment is considered. Allergic Rhinitis has also approved this rout of immunotherapy and its Impact on Asthma (ARIA) for adults with moderate to severe AR.5,6 Until now, Food and Drug Administration approved only, three allergy tablets and no sublingual drops are yet proved. Meanwhile, published literature c
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat,Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/02/2017
Actual trial start date 04/06/2017
Anticipated date of last follow up 01/04/2018
Actual Last follow-up date 11/10/2018
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group skin prick testing Sublingual immunotherapy and traditional pharmacological therapy as required Increasing concentrations of allergen extracts one year Sublingual immunotherapy 60
Control Group Traditional pharmacological therapy for allergy Daily one year Traditional treatment 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescent or adult Patient with a history of moderate to severe chronic allergic rhinoconjunctivitis without any co-morbidities. The study excluded any patient with active, acute, or chronic obstructive pulmonary disease, except for asthma and allergic rhinitis; forced expiratory volume in 1 s ≤ 70% of predicted value; Patients who have disorders concerning drug absorption, distribution, metabolism, and excretion. Inability to perform Skin prick test in patients included in group 2. Illiterate patients who cannot read the self-administered quality of life questioner were also excluded. Refusal of consent. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/12/2016 Zagazig Univeristy Faculty of Medicine Institutional Review Board IRB
Ethics Committee Address
Street address City Postal code Country
Al Gamma Street Zagazig 44519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement of patients Quality of life One year
Secondary Outcome Improvement in patient Medication score One year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Allergy and Immunology Unit Faculty of Medicine Zagazig University Al Gamaa street Zagazig 44519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Dr Reham El Shabrawy Dr Ahmed Saeed Dr Atef Al Bahrawi 11 Attia Al Khamry street Zagazig 44519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Zagazig University Al Gamaa Street Zagazig 44519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr Ahmad Saeed Khalil Dr Atef Al Bahrawi Al Gamaa Street, Faculty of Medicine, Zagazig University Zagazig 44519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reham El Shabrawy Ali reham.elshabrawy@zu.edu.eg +201005275672 11 Attia Al Khamry st
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt Assistant Professor of Medical Microbiology and Immunology
Role Name Email Phone Street address
Public Enquiries Atef El Bahrawi atefelbahrawi@gmail.com +201222430107 Al Gamaa street, Faculty of Medicne, Otolarynrology Departemnt, Zagazig University
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt Professor of Otolaryngeology Faculty of Medicine Zagazig University
Role Name Email Phone Street address
Scientific Enquiries Ahmad Khalil iahmadsaeed1@gmail.com +201221020554 Al Gamaa Street, Faculty of Medicine, Zagazig University, Ophthalmology Department
City Postal code Country Position/Affiliation
Zagazig 5519 Egypt Lecturer of Ophthalmology Faculty of Medicine Zagazig University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information