Investigation of the effectiveness of using 0.65% sodium chloride nasal spray in children aged 6 to 18 years with allergic rhinitis and asthma

This study aims to assess the effectiveness of 0.65% sodium chloride nasal spray versus placebo on symptoms, quality of life, medication use, and asthma control in children with allergic rhinitis

Two-arm, parallel group, double-blind, randomized controlled trial conducted at a single center with a target sample size of 68 participants. Randomization was performed at the individual level using computer-generated simple randomization, and outcome assessment was blinded

This single-center randomized controlled trial will enroll 68 children with allergic rhinitis. Participants will be randomized to intervention or placebo sprays in a double-blind design with participants, providers, investigators, and outcome assessors masked. Ethical approval has been granted and informed consent will be obtained from parents or guardians.

Inclusion criteria: Children aged 6–18 years allergic rhinitis (with or without asthma) confirmed by an allergy specialist Written informed consent Exclusion criteria: Presence of chronic heart or lung disease, chronic pneumonia, or immune deficiency Other nasal diseases such as non-allergic rhinitis, nasal polyps, or septal deviation Withdrawal of consent during the study Development of new medical conditions requiring discontinuation Occurrence of adverse events such as bleeding or drug hypersensitivity

Intervention group: Participants receive 0.65% sodium chloride nasal spray in addition to routine care (cetirizine, montelukast, or seroflo as clinically indicated). Control group: Participants receive placebo nasal spray with identical appearance and packaging in addition to routine care.

Primary outcomes are changes in nasal symptom severity (TNSS), quality of life (RQLQ), medication use, and asthma control over 4 weeks

In this study, randomization was carried out using a simple randomization method with an equal 1:1 allocation ratio between the intervention group and the control group. The unit of randomization was the individual participant, specifically children aged 6–18 years who met the inclusion criteria. The randomization sequence was generated electronically through Randomization.com, a computer-based tool designed for clinical trials. The sequence was created in advance, with assignments prepared in a simple random list, ensuring that each eligible participant had an equal probability of being allocated to either group. During enrollment, participants were assigned sequentially according to the pre-generated list. This approach ensured a straightforward allocation process, though the document does not specify the use of stratification, blocking, or other pseudorandomization techniques. The study was conducted in a double-blind manner, meaning both participants and outcome assessors were unaware of group assignments, and a placebo spray was used to preserve masking.

In this trial, participants were blinded by the use of indistinguishable nasal sprays, with the intervention group receiving 0.65% sodium chloride spray and the control group receiving a placebo spray. The sprays were identical in appearance, packaging, and method of administration, ensuring that participants could not determine their group assignment. Healthcare providers (caregivers delivering the intervention and routine care) were also blinded, since they administered sprays that were identical in form and labeling, and thus could not differentiate between treatment and placebo. The principal investigators and study team responsible for trial oversight remained blinded to allocation throughout participant enrollment and follow-up, thereby preventing any intentional or unintentional bias in patient management or trial conduct. Outcome assessors, who collected symptom scores, quality-of-life measures, and asthma severity indices, were blinded to group allocation, ensuring that clinical assessments and data collection were unbiased. While the data collectors overlapped with outcome assessors and thus remained blinded, the data analysts were not explicitly reported as blinded in the protocol; therefore, it is likely that they had access to group allocation codes during statistical analysis. No Data Safety and Monitoring Board (DSMB) was established for this small investigator-initiated academic study, as DSMBs are typically reserved for large-scale or industry-sponsored trials. Finally, manuscript writers were members of the investigator team and therefore were not independent or blinded at the stage of report preparation.

“Deidentified Individual Participant Data (IPD) set; Study Protocol; Statistical Analysis Plan; Informed Consent Form (template); Data Dictionary.” The IPD will include deidentified baseline characteristics and all outcome measures collected during the trial. The protocol and statistical analysis plan will be the final versions used for the study. The informed consent form will be the final approved template (with personal/contact fields redacted). The data dictionary will define each variable, units, coding, and allowable ranges.

Beginning 6 months after publication of the primary results and continuing for 5 years thereafter.

Qualified researchers from academic or non-profit institutions with a methodologically sound proposal. Industry researchers may also apply if the request aligns with the consent and ethical approvals.

Access will be granted for analyses addressing the research questions described in an approved proposal, contingent on: (1) submission of a brief protocol and analysis plan, (2) evidence of local ethics approval or exemption, (3) signing a Data Use Agreement prohibiting re-identification, unauthorized sharing, and commercial use, and (4) approval by the Data Access Committee (Principal Investigator plus two co-investigators). Data will be provided deidentified via a secure, time-limited link.

Dr.Hamidreza Houshmand

Submit a request including a one-page proposal (objectives, variables requested, analysis plan), proof of ethics approval/exemption, and a signed confidentiality statement. The Data Access Committee will review within ~30 days. If approved, a Data Use Agreement will be issued for signature; upon execution, deidentified data and documents will be shared via secure transfer within ~10 business days.