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Clinical Trials/CTRI/2024/12/078194
CTRI/2024/12/078194
Recruiting
Phase 1

Effectiveness of nasal rehabilitation on nasal symptoms in patients with chronic allergic rhinitis: A randomized control trial

Manipal Academy of Higher Education1 site in 1 country120 target enrollmentStarted: December 25, 2024Last updated:

Overview

Phase
Phase 1
Status
Recruiting
Enrollment
120
Locations
1
Primary Endpoint
Total nasal symptoms score

Overview

Brief Summary

Allergic rhinitis and its impact on asthma [ARIA] define Allergic Rhinitis [AR]as“Type 1 hypersensitive inflammation of the nasal mucosa Induced by exposure to allergic substance.  With at least two or four cardinal nasal symptoms namely sneezing, rhinorrhoea, nasal itching and nasal block present>1 hour/day on most/many days in a year”[1]. The global prevalence of AR is found to be 5% to 50% . In India the prevalence is said to be approximately 22% in adolescents[3].

The early response to the exposure to the allergens causes sneezing, rhinorrhoea, inflammation of mucosal glands and nasal congestion which is mediated by the IgE and lasts for 5 to 15 minutes[4]. The late response which lasts for 4 to 6 hours can causes nasal mucosa production, nasal edema and nasal congestion, which is leukotriene mediated[5].   Based on the symptoms AR can be subdivided  as intermittent [acute] and persistent [chronic]. The AR is said to be acute, If the symptoms of AR are seen for less than 4 weeks or less than 4 days per week and lasting more than that is termed as chronic AR[1][4].  the symptoms of the chronic AR  is same as acute rhinitis but,  the mouth breathing pattern , blueish discoloration of lower eyelids[allergic shiners] seen in the patients with the chronic AR[6] .Mouth breathing can cause reduction in oral hydration, mucociliary clearance, local innate immune defence and mucosal homeostasis due to the lack of oscillatory mechanical pressure that happens in nasal breathing [7][8].There will be reduction in intraoral space which can cause obstruct the pharyngeal airway , nasal muscle dysfunction in mouth breathing[9] .Numerous studies have proven the adverse effect of mouth breathing[10][11][12] . Additionally, some research suggests that improving oral breathing problems does not always result from orthodontic treatment that enlarges the nasal cavity[9] .

The diagnosis of the AR is done by skin prick testing, rhinoscopy and allergic specific IgE test[2].  Pharmacological treatment in AR includes intranasal corticosteroids, antihistamines decongestants, leukotriene receptor antagonists and immunotherapy. All these drugs have several side effects and also increase dependency on drugs[3]. Surgical approach in the AR include inferior turbinate reduction, lateralization outfracture, laser vaporization, radiofrequency abalation and cobalation, sub mucosal resection, septoplasty and endoscopic sinus surgery[14]. Non pharmacological approach include nasal rehabilitation, which could be an alternative measure. There is lack of literature in  the study to evaluate both mouth breathing and nasal symptoms in patients with chronic allergic rhinitis existing literature lack assessment of mouth breathing in patients with chronic allergic rhinitis.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients diagnosed with chronic allergic rhinitis by pulmonologist.

Exclusion Criteria

  • Severe seasonal allergic rhinitis, craniofascial disorder, tracheostomy dependence, prior history of laryngeal, subglottic or pulmonary airway stenosis or surgery, severe psychological problems, other lower respiratory tract disorders, smokers.

Outcomes

Primary Outcomes

Total nasal symptoms score

Time Frame: Baseline and every week for five weeks

Secondary Outcomes

  • Nasal obstruction symptom evaluation score(Baseline and after five weeks)
  • Rhinoconjunctivitis quality of life questionnaire(Baseline and after five weeks)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Sachin Tendulkar

Manipal College of Health Professions, Manipal Academy of Higher Education

Study Sites (1)

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