Hypertonic Saline Nasal Irrigation and Gargling for the Common Cold. (ELVIS)
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|ClinicalTrials.gov Identifier: NCT02438579|
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : December 15, 2015
Viral upper respiratory tract infections (URTI), one of the commonest infection faced by humans, have a significant impact on individuals, families, health service and economy. Though rhinoviruses are called the "common cold virus", numerous viruses can cause URTI. Hence virus specific remedy for URTI is impractical. There are currently no evidence-based interventions that reduce the severity, symptom duration or viral shedding. Preliminary evidence suggests that hypertonic saline nasal irrigation and gargling (HSNIG) may reduce the duration of symptoms.
With this pilot randomised controlled trial (RCT), the investigators aim to assess the feasibility of undertaking a definitive RCT of HSNIG in adults with URTI. This pilot focuses on recruitment rate, willingness to be randomised, acceptability, compliance and likely effect size of the intervention.
This pilot RCT compares HSNIG vs. usual care in 60 adults. Serial self-collected mid-turbinate swabs will help assess change in viral shedding. Symptomatic relief is measured by a validated symptom score. A questionnaire based participant feedback will help assess intervention and trial procedures.
This mixed-methods pilot trial will help inform plans for a definitive RCT of this low-cost intervention that has the potential of substantial health and societal benefits.
|Condition or disease||Intervention/treatment||Phase|
|Common Cold Upper Respiratory Tract Infections||Other: Nasal Irrigation & Gargling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Edinburgh and Lothians Viral Intervention Study (ELVIS). A Pilot Randomised Control Trial of Hypertonic Saline Nasal Irrigation and Gargling on Individuals With the Common Cold to Assess Recruitment, Retention, Side Effects & Effectiveness|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Nasal Irrigation & Gargling
Videos on how to collect nasal swabs, prepare and perform hypertonic saline nasal irrigation and gargling (HSNIG) are shown. A nasal swab is collected. Participant chooses the highest concentration of hypertonic saline he/she is comfortable with (from 1.5, 2.0, 2.5 and 3.0%) and performs HSNIG under observation. Nasal swabs are to be collected first thing in the morning on 4 consecutive days and posted using the Royal Mail Safebox. Daily diaries are to be completed (online / paper form) until they document "not unwell" for two consecutive days; or a maximum of 14 days or if they need medical attention for the URTI. Swabs are tested in parallel to detect change in viral shedding.
Other: Nasal Irrigation & Gargling
Participants are advised to perform the intervention as frequently as required (expected frequency around 6 times a day for the first two days, reducing in frequency from day 3 as symptoms improve).
No Intervention: Control
The control group are advised to manage the URTI as they normally do. A video on how to collect nasal swabs is shown. A nasal swab is collected. Nasal swabs are to be collected first thing in the morning on 4 consecutive days and posted using the Royal Mail Safebox. Daily diaries are to be completed (online / paper form) until they document "not unwell" for two consecutive days; or a maximum of 14 days or if they need medical attention for the URTI. Swabs are tested in parallel to detect change in viral shedding.
- What is the recruitment rate? [ Time Frame: 6 months ]A standard accrual plot will be produced, a plot of number of participants recruited in each week and the recruitment rate will be expressed as the average number of participants recruited per week over the duration of the study period. A table showing number of participants recruited by site will also be produced.
- What is the rate of sample return within the two arms? [ Time Frame: 6 months ]The overall number of participants returning swabs, will be presented as numbers/percentages [with 95% confidence intervals (CI) for the percentages]. Differences between the groups will be assessed using a binomial test for the comparison of proportions and expresses as a percentage [with 95% CI].
- What is the rate of diary completion within the two arms? [ Time Frame: 6 months ]The overall number of participants completing diaries will be presented as numbers/percentages [with 95% CI]. Differences between the groups will be assessed using a binomial test for the comparison of proportions and expresses as a percentage [with 95% CI].
- Do the participants comply with the intervention regime? [ Time Frame: 6 months ]The overall number of participants following treatment as per protocol will be presented as numbers/percentages [with 95% CI]. Differences between the groups will be assessed using a binomial test for the comparison of proportions and expresses as a percentage [with 95% CI].
- What are the participant views on acceptability? [ Time Frame: 6 months ]Responses to participant acceptability will be presented as numbers and percentages split by treatment arm.
- Is there a difference between arms in their quality-of-life? [ Time Frame: 6 months ]A persons average quality of life as measured by the EQ-VAS daily over the study period will be calculated and compared between treatment groups using a two-sample t-test or non-parametric equivalent as appropriate. Rate of change will also be compared between groups in the same manner where the rate of change will be determined by: ([final day EQ-VAS] - [baseline EQ-VAS]) / (number of days - 1)
- Is there a difference between arms in the duration of symptoms or viral shedding? [ Time Frame: 6 months ]
Duration of symptoms will be defined by WURSS-21-Scot [time to reach a score of 0 for two consecutive days]. If appropriate to treat as a continuous variable, a two-sample t-test or non-parametric equivalent will be used as appropriate. However it may be more appropriate to treat the time a categorical measure, if this is the case we will use Chi-square/Chi-square test for trend as appropriate. In addition to this the average WURSS-21-Scot will be compared between treatment arms using the same methods.
Chi-square test and chi-square test for trend will be used as appropriate to determine if there is a difference in viral shedding between arms. Viral load is measured daily for the first 4 days and reported using CT values, we will estimate the slope of the line for each participant and a comparison will be made between groups. In addition to this average CT value and average log copies above level of detection will be compared across groups using a two-sample t-test.
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): NCT02438579
|Royal Infirmary of Edinburgh|
|Edinburgh, Midlothian, United Kingdom, EH16 4SA|
|Principal Investigator:||Sandeep Ramalingam, PhD, FRCPath||NHS Lothian|