Allergic RhinitisPhase 2NCT01441778
Efficacy of Buffered Hypertonic Saline(BHS)Nasal Irrigation in Allergic Rhinitis (AR) Children
A Phase 2 study testing NSS nasal irrigation salt and BHS nasal irrigation salt in people with Allergic Rhinitis, run by Thammasat University at 1 site in Thailand.
Trial summary
The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms in children with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- NSS nasal irrigation salt and BHS nasal irrigation salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2010to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 6-15 years
- diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology
- TNSS ≥ 4 at the first visit of this study
Who cannot join
- Patients with a history of nasal anatomical defects
- Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Buffered Hypertonic Saline Nasal Irrigation in Children With Symptomatic Allergic Rhinitis : A Randomized Double-blind Study.
The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms in children with allergic rhinitis.
Read the detailed description
- BHS is superior to NSS for improving mucociliary function that by measure saccharine clearance time(SCT)at 10 minute after nasal irrigation compare to baseline.
- BHS is superior to NSS for clinical effectiveness at short period and 1 month follow up
- at short period: compare the following results at baseline and 10 minute after nasal irrigation
- total nasal symptom score(TNSS)
- satisfaction to nasal irrigation
- side effect
- at 2 and 4 weeks follow up : compare the following results at baseline and 10 minute after nasal irrigation
- quality of life(by specific questionnaire for Thai allergic rhinoconjunctivitis patient)
- medication use to relieve AR symptom(from diary record)
- compliance for nasal irrigation (from diary record)
- side effect (from diary record)
- overall satisfaction to nasal irrigation
- Conditions
- Allergic Rhinitis
- Being tested
- NSS nasal irrigation salt, BHS nasal irrigation salt
- Keywords
- nasal irrigation, allergic rhinitis, children
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSS nasal irrigation saltDrug
Also called NORMALINE
nasal irrigation twice daily for 4 weeks period
BHS nasal irrigation saltDrug
Also called SEANIS
nasal irrigation twice daily for 4 weeks period
| Study group | Role | What they receive |
|---|---|---|
| NSS irrigation salt | Active comparator | Not described Receives: Drug: NSS nasal irrigation salt |
| BHS nasal irrigaiton salt | Experimental | Not described Receives: Drug: BHS nasal irrigation salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS
SCT method : subjects seated with their head upright. A rhinoprobe was used to place a small piece of saccharine on the medial aspect of the inferior turbinate approximately 1 cm, posterior to the nasal vestibule. The SCT was recorded as the subject's first perception of a sweet taste.
Measured: baseline, 10 minute after nasal irrigaiton
Secondary outcomes (1)
The effect of BHS and NSS on clinical effectiveness
evaluate total nasal symptom score, side effect, satisfaction for nasal irrigation, quality of life at 1st visit, 2nd week and 4 week follow up
Measured: 1st visit, 2nd week and 4 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, araya satdhabudha, Thammasat University
- Investigators
- Araya Satdhabudh, MD, Principal investigator, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441778
- Sponsor's protocol ID
- MTU-PE-2-CR038-038/53
- Other IDs
- 14/2553
- Status last verified
- Sep 2011
- First submitted
- 21 Sep 2011
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Buffered Hypertonic Saline Nasal Irrigation in Children With Symptomatic Allergic Rhinitis : A Randomized Double-blind Study.
- ClinicalTrials.gov ID
- NCT01441778
- Acronym / sponsor ID
- MTU-PE-2-CR038-038/53
- Conditions
- Allergic Rhinitis
- Keywords
- nasal irrigation, allergic rhinitis, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms in children with allergic rhinitis.
Detailed description
- BHS is superior to NSS for improving mucociliary function that by measure saccharine clearance time(SCT)at 10 minute after nasal irrigation compare to baseline.
- BHS is superior to NSS for clinical effectiveness at short period and 1 month follow up
- at short period: compare the following results at baseline and 10 minute after nasal irrigation
- total nasal symptom score(TNSS)
- satisfaction to nasal irrigation
- side effect
- at 2 and 4 weeks follow up : compare the following results at baseline and 10 minute after nasal irrigation
- quality of life(by specific questionnaire for Thai allergic rhinoconjunctivitis patient)
- medication use to relieve AR symptom(from diary record)
- compliance for nasal irrigation (from diary record)
- side effect (from diary record)
- overall satisfaction to nasal irrigation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSS irrigation salt | Active comparator | Drug: NSS nasal irrigation salt |
| BHS nasal irrigaiton salt | Experimental | Drug: BHS nasal irrigation salt |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 6-15 years
- diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology
- TNSS ≥ 4 at the first visit of this study
Key exclusion criteria (2 listed)
- Patients with a history of nasal anatomical defects
- Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSS nasal irrigation saltAlso: NORMALINEnasal irrigation twice daily for 4 weeks period | Drug | NSS irrigation salt |
| BHS nasal irrigation saltAlso: SEANISnasal irrigation twice daily for 4 weeks period | Drug | BHS nasal irrigaiton salt |
Primary outcome
The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS
Time frame: baseline, 10 minute after nasal irrigaiton
SCT method : subjects seated with their head upright. A rhinoprobe was used to place a small piece of saccharine on the medial aspect of the inferior turbinate approximately 1 cm, posterior to the nasal vestibule. The SCT was recorded as the subject's first perception of a sweet taste.
1 secondary outcome
The effect of BHS and NSS on clinical effectiveness
Time frame: 1st visit, 2nd week and 4 week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Araya Satdhabudh, MD principal investigator
Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NSS nasal irrigation salt and BHS nasal irrigation salt in people with Allergic Rhinitis, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS (time frame: baseline, 10 minute after nasal irrigaiton). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2011.