Allergic rhinitis is defined as the symptoms of sneezing, nasal itching, airflow obstruction
and, mostly, clear nasal discharge caused by IgE-mediated reactions against inhaled allergens
and involving mucosal inflammation driven by T cells (Th2) auxiliary type 2. pollens and
molds, as well as allergens from perennial interiors, such as dust mites, pets, pests and
some molds. The pattern of dominant allergens depends on the geographic region and degree of
urbanization, but the general prevalence of sensitization to allergens does not vary among
census districts in the United States.2 Sensitization to inhaled allergens begins during the
first year of life; Sensitization to indoor allergens precedes sensitization to pollens.
Because viral respiratory infections occur frequently in young children and produce similar
symptoms, it is very difficult to diagnose allergic rhinitis in the first 2 or 3 years of
life. The prevalence of allergic rhinitis reaches its peak in the second to fourth decades of
life and then gradually decreases.
The frequency of sensitization to inhaled allergens is increasing and is now more than 40% in
many populations in the United States and Europe. The prevalence of allergic rhinitis in the
United States is approximately 30%. Allergic rhinitis contributes to lost or unproductive
time at work and school, to sleep problems and among affected children, to less participation
in outdoor activities. In addition, children with allergic rhinitis are more likely than
unaffected children to have myringotomy tubes placed and their tonsils and adenoids removed.
The ability to control asthma in people with asthma and allergic rhinitis has been linked to
the control of allergic rhinitis.
Most people with asthma have rhinitis. The presence of allergic rhinitis (seasonal or
perennial) significantly increases the likelihood of asthma: up to 40% of people with
allergic rhinitis have or will have asthma. It is also important to define the physiological
functional breathing of obstructive sleep apnea (OSA). Functional or physiological breathing
is through the nose, while OSA is the collapse of the muscles of the oropharyngeal airways.
Nasal obstruction and OSA are usually comorbid. Therapies to increase nasal volume and
airflow in compromised patients have a significant benefit in reducing the symptoms of
nighttime and daytime respiratory disorders.
The nose represents more than 50% of the total resistance of the upper airway and plays an
important role in the establishment of physiological functions such as humidification,
heating and air filtration. The nasal mucosa is a dynamic organ controlled by the autonomic
nervous system. Periodic nasal congestion and decongestion have been termed the "nasal
cycle." In patients with permanent unilateral nasal obstruction, the nasal cycle can
contribute to a significant increase in total resistance of the respiratory tract.
Each nasal inhalation mixes nitric oxide (NO) gas from the maxillary sinuses and is
transported to the lungs. It is NOT necessary for the movement of the cilia in the paranasal
sinuses to carry out the waste, it is anti-fungal, antibacterial and anti-viral, it is also
important in the peripheral vasodilatation of the blood vessels. In selected patients, it was
recommended that the final point to treat OSA be the restoration of nasal breathing.
Resistance of the upper respiratory tract can cause an increase in blood pressure. Mouth
breathing does not have any of the mechanisms of physiological protection, so that people
with this condition are more prone to respiratory infections, as well as to dental sequelae
(gum disease, open anterior bite). That is why the investigators propose to study the
combination of an antihistamine with more than 60 years in the market that was studied
intranasal in the 50s. Nowadays it is known that the combination of antihistamine have better
effect, less side effects than oral treatments. In the US and Europe, a combination of
steroids with antihistamine of European origin is available only by recipes and is highly
expensive. This research proposes to study a separate antihistamine in a nasal spray. It is
important to note that this antihistamine is available without prescription (OTC) and has
been studied intranasal since the 1950s1,2.
Method
A multicenter, randomized, double-blind, 14-day study will be conducted during the spring of
2019. After starting 5 days of placebo therapy, 100 patients from each group with moderate to
severe nasal symptoms will be randomized to treatment. with (1) chlorpheniramine nasal spray
vs placebo (nasal saline). All treatments will be administered in the form of 1 spray per
nostril twice a day. The main variable of effectiveness will be the change from the beginning
in the total score of nasal symptoms (TNSS), which consists of nasal congestion, nasal
discharge, nasal itching and sneezing. The main efficacy variables will be (1) the change
from the beginning to day 14 in the total reflective nasal symptom score (TNSS) in the first
12 hours, which combines scores for rhinorrhea, sneezing, itchy nose and nasal congestion,
and (2) Start of Action, based on the instant TNSS for 4 hours after the first dose of the
study drug. During the double-blind treatment period, patients will record their symptom
scores on daily cards twice a day (morning and afternoon). Patients older than or equal to 18
years will complete the questionnaire on the quality of life of rhinoconjunctivitis (RQLQ) at
the beginning of the study and on day 14. Patients will be instructed to call the office at
any time for any questions . Follow-up appointments will be in 1 week, two, and four weeks.