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AzTrials

AsthmaPhase 4NCT00903227

Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

A Phase 4 study testing Fluticasone Evohaler pMDI, Fluticasone Evohaler and fluticasone propionate (Flixonase®) in people with Asthma and Allergic Rhinitis, run by University of Dundee at 1 site in United Kingdom.

Completed

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

Official record
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Trial summary

Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway inflammation with topical steroids improves the twitchiness of the airways (hyperresponsiveness) and overall asthma control. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma, Allergic Rhinitis
What is being tested?
Fluticasone Evohaler pMDI, Fluticasone Evohaler and fluticasone propionate (Flixonase®)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2006to Aug 2008
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mild to moderate atopic asthmatics with FEV1 ≥ 60% on ≤ 1000 ug BDP and concomitant persistent allergic rhinitis (SPT +ve and PC20 < 4 mg/ml)
  • Male or female aged 18-65 years
  • Informed Consent
  • Ability to comply with the requirements of the protocol

Who cannot join

  • Severe asthmatics as defined by an FEV1 ≤ 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms.
  • Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
  • The use of oral corticosteroids within the last 3 months
  • Recent respiratory tract infection (2 months)
  • Significant concomitant respiratory disease
  • Any other significant medical condition or investigation which may jeopardise the safety of the participant or the conduct of the protocol
Show all 10Show fewer
  • Any significant abnormal laboratory result as deemed by the investigators
  • Pregnancy, planned pregnancy or lactation
  • Known or suspected contra-indication to any of the IMP's
  • Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee

    Dundee, Angus, DD1 9SY

Other trials in United Kingdom

About this study

Official title: A Proof Of Concept Study To Assess The Steroid Sparing Effect Of Combined Nasal And Inhaled Corticosteroid In Patients With Asthma And Persistent Rhinitis

Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway inflammation with topical steroids improves the twitchiness of the airways (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves quality of life. While there is evidence that combined treatment of the nose and the lungs with topical steroids improves symptoms and underlying inflammation, it is unclear whether such control can be achieved using a smaller dose of inhaled steroid in combination with nasal steroid. It is therefore the intention of this study to evaluate if combination steroid therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis using sensitive markers of airway inflammation.

Being tested
Fluticasone Evohaler pMDI, Placebo, Fluticasone Evohaler, Placebo intranasal spray, fluticasone propionate (Flixonase®)
Keywords
Asthma, Allergic rhinitis, fluticasone, methacholine
Medical subject headings
Asthma, Rhinitis, Allergic

What participants receive

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

  • Fluticasone Evohaler pMDIDrug

    One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)

  • PlaceboDrug

    1 puff of inhaled Placebo twice a day

  • Fluticasone EvohalerDrug

    One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)

  • Placebo intranasal sprayDrug

    placebo intranasal spray 2 squirts each nostril once a day

  • fluticasone propionate (Flixonase®)Drug

    intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts

Study groups in NCT00903227
Study groupRoleWhat they receive
Low DoseExperimentalOne puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg) and 1 puff of inhaled Placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.
Receives: Drug: Fluticasone Evohaler pMDI; Drug: Placebo; Drug: Placebo intranasal spray
CombinedExperimentalOne puff of inhaled fluticasone propionate Evohaler pMDI 50 µg twice a day (Total daily FP dose 100 µg) and 1 puffs of Placebo twice a day with intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts each nostril once a day (i.e. total intranasal FP daily dose 200ug).
Receives: Drug: Fluticasone Evohaler pMDI; Drug: Placebo; Drug: fluticasone propionate (Flixonase®)
High doseExperimentalOne puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg) and 1 puff of inhaled placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.
Receives: Drug: Placebo; Drug: Fluticasone Evohaler; Drug: Placebo intranasal spray

What is being measured

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

  1. methacholine PC20

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

Secondary outcomes (9)

  1. Spirometry

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

  2. Juniper AQLQ

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

  3. Fractionated Nitric Oxide

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

  4. serum ECP

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

  5. blood eosinophils

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

  6. Overnight urinary cortisol creatinine

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

  7. Peak Nasal Inspiratory Flow rate

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

  8. Nasal Nitric Oxide

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

  9. Juniper mini RQLQ

    Measured: 0, 2, 4, 6, 8, 10, 12 weeks

Timeline

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

  1. First posted18 May 2009 (estimated)
  2. Study startDec 2006
  3. Primary completionAug 2008
  4. Study completionAug 2008

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
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00903227
Sponsor's protocol ID
NAI03
Other IDs
2005-005557-22, 2005
Status last verified
Oct 2019
First submitted
14 May 2009
Last updated
16 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • Corren J. Allergic rhinitis and asthma: how important is the link? J Allergy Clin Immunol. 1997 Feb;99(2):S781-6. doi: 10.1016/s0091-6749(97)70127-1.

    PubMed 9042071

  • Reed CE, Marcoux JP, Welsh PW. Effects of topical nasal treatment on asthma symptoms. J Allergy Clin Immunol. 1988 May;81(5 Pt 2):1042-7. doi: 10.1016/0091-6749(88)90177-7.

    PubMed 3131406

  • Dahl R, Nielsen LP, Kips J, Foresi A, Cauwenberge P, Tudoric N, Howarth P, Richards DH, Williams M, Pauwels R; SPIRA Study Group. Intranasal and inhaled fluticasone propionate for pollen-induced rhinitis and asthma. Allergy. 2005 Jul;60(7):875-81. doi: 10.1111/j.1398-9995.2005.00819.x.

    PubMed 15932376

  • Bousquet J, Reid J, van Weel C, Baena Cagnani C, Canonica GW, Demoly P, Denburg J, Fokkens WJ, Grouse L, Mullol K, Ohta K, Schermer T, Valovirta E, Zhong N, Zuberbier T. Allergic rhinitis management pocket reference 2008. Allergy. 2008 Aug;63(8):990-6. doi: 10.1111/j.1398-9995.2008.01642.x.

    PubMed 18691301

  • Nair A, Vaidyanathan S, Clearie K, Williamson P, Meldrum K, Lipworth BJ. Steroid sparing effects of intranasal corticosteroids in asthma and allergic rhinitis. Allergy. 2010 Mar;65(3):359-67. doi: 10.1111/j.1398-9995.2009.02187.x. Epub 2009 Oct 5.

    PubMed 19804441

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluticasone Evohaler pMDI, Fluticasone Evohaler and fluticasone propionate (Flixonase®) in people with Asthma and Allergic Rhinitis, run by University of Dundee at 1 site in United Kingdom.

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 4 inclusion and 10 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 16 Oct 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

methacholine PC20 (time frame: 0, 2, 4, 6, 8, 10, 12 weeks). 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 NCT00903227, which also lists 5 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 16 Oct 2019.

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