AzTrials
AzTrials

Allergic RhinitisEarly Phase 1NCT04077892

Compare the Effect of INS Alone and Added LTRA in Treatment of SAR

A Early Phase 1 study testing budesonide in people with Allergic Rhinitis, run by Beijing Tongren Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

It is not proven unequivocally whether a combination of an intranasal corticosteroids (INS) and a cysteinyl leukotriene receptor antagonist has greater efficacy than INS in the treatment of severe allergic rhinitis (AR) . Read more about this study

Who is it for?
Ages 18 to 47 years
Conditions the study is for
Allergic Rhinitis
What is being tested?
budesonide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
1 Jun 2016to 30 Sep 2016
Phase
Early Phase 1
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 18 to 47 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • moderate to severe seasonal allergic rhinitis
  • confirmed to had a diagnosis of SAR and also shown to be sensitized to mugwort allergen
  • had not received any therapies for AR or antibiotics for at least 7 days before their outpatient clinic visit prior to the study

Who cannot join

  • smokers
  • asthma (based on patient's history and pulmonary function tests)
  • had any other chronic disease
  • pregnant women

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Randomized Trial of Comparing a Combination of Montelukast and Budesonide With Budesonide in Allergic Rhinitis

It is not proven unequivocally whether a combination of an intranasal corticosteroids (INS) and a cysteinyl leukotriene receptor antagonist has greater efficacy than INS in the treatment of severe allergic rhinitis (AR) . We performed a randomized, open-label study in 46 seasonal AR subjects receiving budesonide (BD, 256ug) plus montelukast (MNT, 10 mg) or BD alone (256ug) for 2 weeks. Visual analog scale (VAS) scores, nasal cavity volume (NCV), nasal airway resistance (NAR) and fractional exhaled nitric oxide (FeNO) were assessed before and at end of treatments as the primary treatment outcomes. Similarly, histamine, eosinophil cationic protein (ECP) and cysteinyl-leukotrienes (Cyslts) in nasal secretion and Th1/Th2 cells in nasal mucosa were evaluated as the secondary treatment outcomes.

Being tested
budesonide
Keywords
budesonide, montelukast, combination therapy, monotherapy
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • budesonideDrug

    Also called montelukast

    SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days

Study groups in NCT04077892
Study groupRoleWhat they receive
combination of budesonide and montelukastExperimentalreceive treatment with either a combination of budesonide (Rhinorcort Astra Zeneca AB), 1 spray per nostril twice daily (total 256 μg/d) and 10mg oral montelukast tablet (Merck Sharp \& Dohme Australia Pty Ltd) in the evening for 14 days (BD+MNT treatment group)
Receives: Drug: budesonide
only intranasal budesonideActive comparatortreatment with only intranasal budesonide 1 spray per nostril twice daily for 14 days (BD treatment group)
Receives: Drug: budesonide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of subjective AR symptoms

    The participants were asked by one investigator to fill in a questioner detailing the presence of nasal and eye symptoms (including nasal congestion, rhinorrhea, nasal itching, sneezing and eye itching), and to score each symptom on a 0-10 cm scale; with 0 cm = no symptoms and 10 cm = most severe and bothersome symptom. The same investigator calculated both the individual symptom and the average of the sum of 5 AR symptoms scores, before and at the end of 14 days' treatment. Any subject with a mean score of < 4 cm at baseline was excluded from this study.

    Measured: at baseline, 14 days

Secondary outcomes (2)

  1. The change of objective examination: nasal patency

    Eccovision acoustic rhinometry was used to measure the nasal cavity volume (NCV) according to standardized recommendations. Measurements of nasal volume were made from the first 2 cm (V2), the first 4 cm (V4), from the first 6 cm (V6), from the segment between 0 and 5 cm (V0-5), and the segment between 0 and 7 cm (V0-7) of the nose. All measurements were performed three times by the same operator, and nasal volumes were calculated as the sum of both nostrils24. In the current study, the change in the nasal cavity volume was measured at 2-5 cm, as this seems to be an important variable for mucosal changes.24 Nasal airway resistance (NAR) was measured by anterior active rhinomanometry in a quiet room at temperature of 25°C and humidity of 70%. NAR was measured at 75 Pa point (R75T).

    Measured: at baseline, 14 days

  2. The change of Fractional Exhaled NO

    A nitric oxide analyser was used to measure exhaled nasal nitric oxide (nNO). Briefly, NO-free air was aspirated through the nasal cavity at a flow rate of 50 ml/s. The subject exhaled against the air-resistance, resulting in an intraoral pressure to close the velum and prevent mixture of oral and nasal gas. Nasal gas from this circuit was continuously routed in part directly into the analyser for determination of nNO, and the level of nNO(ppb) was calculated from a plateau lasting for at least 3s.

    Measured: at baseline, 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2019
  2. Study start1 Jun 2016
  3. Primary completion30 Sep 2016
  4. Study completion30 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04077892
Sponsor's protocol ID
TR-INS&LTRA-AR
Status last verified
Sep 2019
First submitted
1 Sep 2019
Last updated
4 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Price DB, Swern A, Tozzi CA, Philip G, Polos P. Effect of montelukast on lung function in asthma patients with allergic rhinitis: analysis from the COMPACT trial. Allergy. 2006 Jun;61(6):737-42. doi: 10.1111/j.1398-9995.2006.01007.x.

    PubMed 16677244

  • Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.

    PubMed 20816182

  • Priftis KN, Drigopoulos K, Sakalidou A, Triga M, Kallis V, Nicolaidou P. Subjective and objective nasal obstruction assessment in children with chronic rhinitis. Int J Pediatr Otorhinolaryngol. 2006 Mar;70(3):501-5. doi: 10.1016/j.ijporl.2005.07.027. Epub 2005 Sep 9.

    PubMed 16154642

  • Henriksen AH, Sue-Chu M, Holmen TL, Langhammer A, Bjermer L. Exhaled and nasal NO levels in allergic rhinitis: relation to sensitization, pollen season and bronchial hyperresponsiveness. Eur Respir J. 1999 Feb;13(2):301-6. doi: 10.1034/j.1399-3003.1999.13b14.x.

    PubMed 10065672

  • Taylor DR, Pijnenburg MW, Smith AD, De Jongste JC. Exhaled nitric oxide measurements: clinical application and interpretation. Thorax. 2006 Sep;61(9):817-27. doi: 10.1136/thx.2005.056093.

    PubMed 16936238

  • American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.

    PubMed 15817806

  • Clement PA, Gordts F; Standardisation Committee on Objective Assessment of the Nasal Airway, IRS, and ERS. Consensus report on acoustic rhinometry and rhinomanometry. Rhinology. 2005 Sep;43(3):169-79.

    PubMed 16218509

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing budesonide in people with Allergic Rhinitis, run by Beijing Tongren Hospital at 1 site in China.

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 4 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 4 Sep 2019. 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 China. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 of subjective AR symptoms (time frame: at baseline, 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04077892, which also lists 7 linked publications.

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 4 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in