Allergic RhinitisPhase 4NCT00845598
Azelastine Fluticasone Combination vs. Fluticasone
A Phase 4 study testing Azelastine , fluticasone and Fluticasone propionate in people with Allergic Rhinitis, run by University of Dundee at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to see how a combination spray of azelastine and fluticasone (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in allergic rhinitis i.e. does azelastine permit the use of lesser steroid dose (steroid sparing effect) to achieve the same benefit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Azelastine , fluticasone and Fluticasone propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2010to Aug 2011
- 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
- Male of Female aged 18-65 years.
- Persistent allergic rhinitis with or without asthma.
- Atopy to at least one allergen on SPT.
- Ability to give a written informed consent.
- Ability and willingness to comply with the requirements of the protocol.
Who cannot join
- Recent respiratory tract/sinus infection within the last 2 months. .
- Pregnancy, planned pregnancy or lactation.
- Known or suspected hypersensitivity to any of the IMP's.
- Concomitant use of medicines (prescribed, OTC or herbal) like alpha blockers that may interfere with the trial.
- Nasal Polyposis grade 2+, Deviated nasal septum ≥ 50%
- The use of oral corticosteroids within the last 3 months.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Ninewells Hospital and Medical School
Dundee, DD1 9SY
Perth Royal Infirmary
Perth, PH1 1NX
About this study
Official title: A Proof of Concept Study to Evaluate Comparative Efficacy of an Azelastine/Fluticasone Combination Nasal Spray vs. Twice the Dose of Fluticasone in Persistent Allergic Rhinitis
The purpose of this study is to see how a combination spray of azelastine and fluticasone (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in allergic rhinitis i.e. does azelastine permit the use of lesser steroid dose (steroid sparing effect) to achieve the same benefit.
Read the detailed description
Allergic rhinitis (AR) is a major chronic respiratory disease with a prevalence approaching nearly 25% in the worldwide population.Allergic Rhinitis is a common and relatively undiagnosed public health problem and has been reported as being one of the ten most common causes for outpatient attendances to the general practitioner. Long term untreated allergic rhinitis may lead on to asthma. When exposed to allergens (pollen, house dust mite etc) in the atmosphere, the mast cells in the nose burst and an inflammatory response is triggered and patients experience sneezing, itching, blocked nose and running. These allergens may be used as provocation agents to recreate the disease symptoms to confirm the diagnosis of which allergens one is allergic to. However, there is a risk of allergic reactions in doing so. Adenosine monophosphate (AMP)achieves the same goal by stimulating the mast cells and causing them to burst without actually the risks of allergen provocation tests. Such tests are now commonplace in research and clinical medicine. Nasal steroids are considered to be the most potent medications for allergic rhinitis, particularly nasal blockage. Nasal antihistamines are also available but they act mainly to limit nasal running, itching and sneezing and have lesser effect on blockage. The other advantage is that they act very quickly while steroids take at least 72 hours to begin acting and weeks to achieve maximal benefit. Finally, they are free of significant short and long term side effects. Having said that nasal steroids are very safe and unlike inhaled or oral steroids have not been shown to cause systemic side effects in adults. Therefore, it is interesting to see if a combination of an antihistamine and nasal steroid would add their good qualities mentioned above and by the act of reducing the dose of steroid reduce their side effects. To do this we will use nasal AMP challenge as an outcome measure as we have done research studies for over a decade with. We will look at noninvasive nasal airflow parameters, nasal nitric oxide levels, and for safety we will look at the overnight urinary cortisol and creatinine ratio which is the most sensitive and noninvasive test of urine to quantify how much steroid has been absorbed in the blood stream.
- Conditions
- Allergic Rhinitis
- Being tested
- Azelastine , fluticasone, Fluticasone propionate
- Keywords
- Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelastine , fluticasoneDrug
Azelastine Hydrochloride BP 0.10% w/v AND Fluticasone propionate BP 0.0357% w/v as combination
1 squirt in each nostril twice daily
Fluticasone propionateDrug
Fluticasone propionate 0.05% w/w 2 squirts in each nostril (50 μg per squirt)
| Study group | Role | What they receive |
|---|---|---|
| Azelastine Fluticasone | Experimental | Not described Receives: Drug: Azelastine , fluticasone |
| Fluticasone propionate | Active comparator | Not described Receives: Drug: Fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum percentage fall in PNIF after 400mg/ml of AMP nasal challenge between both groups.
Measured: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary outcomes (6)
60 minute recovery to AMP challenge
Measured: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Mini RQLQ
Measured: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Global visual analogue scale
Measured: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Nasal lavage for cytokines
Measured: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Overnight urinary cortisol creatinine ratio
Measured: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Domiciliary diary cards
Measured: 2 week treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Why it stopped: Could not get IMP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian J Lipworth, University of Dundee
- Investigators
- Sriram Vaidyanathan, MBBS, Principal investigator, University of DundeeBrian Lipworth, MD, FRCP, Study director, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845598
- Sponsor's protocol ID
- VAI04
- Status last verified
- Jun 2012
- First submitted
- 17 Feb 2009
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bousquet J, Van Cauwenberge P, Khaltaev N; Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001 Nov;108(5 Suppl):S147-334. doi: 10.1067/mai.2001.118891. No abstract available.
PubMed 11707753Nassef M, Shapiro G, Casale TB; Respiratory and Allergic Disease Foundation. Identifying and managing rhinitis and its subtypes: allergic and nonallergic components--a consensus report and materials from the Respiratory and Allergic Disease Foundation. Curr Med Res Opin. 2006 Dec;22(12):2541-8. doi: 10.1185/030079906x158057.
PubMed 17265594Nolte H, Nepper-Christensen S, Backer V. Unawareness and undertreatment of asthma and allergic rhinitis in a general population. Respir Med. 2006 Feb;100(2):354-62. doi: 10.1016/j.rmed.2005.05.012. Epub 2005 Jul 11.
PubMed 16005621Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
PubMed 15080802Weiner JM, Abramson MJ, Puy RM. Intranasal corticosteroids versus oral H1 receptor antagonists in allergic rhinitis: systematic review of randomised controlled trials. BMJ. 1998 Dec 12;317(7173):1624-9. doi: 10.1136/bmj.317.7173.1624.
PubMed 9848901Meltzer EO, Weiler JM, Dockhorn RJ, Widlitz MD, Freitag JJ. Azelastine nasal spray in the management of seasonal allergic rhinitis. Ann Allergy. 1994 Apr;72(4):354-9.
PubMed 7908778Newson-Smith G, Powell M, Baehre M, Garnham SP, MacMahon MT. A placebo controlled study comparing the efficacy of intranasal azelastine and beclomethasone in the treatment of seasonal allergic rhinitis. Eur Arch Otorhinolaryngol. 1997;254(5):236-41. doi: 10.1007/BF00874095.
PubMed 9195148Berger WE, Fineman SM, Lieberman P, Miles RM. Double-blind trials of azelastine nasal spray monotherapy versus combination therapy with loratadine tablets and beclomethasone nasal spray in patients with seasonal allergic rhinitis. Rhinitis Study Groups. Ann Allergy Asthma Immunol. 1999 Jun;82(6):535-41. doi: 10.1016/s1081-1206(10)63161-4.
PubMed 10400480
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate Comparative Efficacy of an Azelastine/Fluticasone Combination Nasal Spray vs. Twice the Dose of Fluticasone in Persistent Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00845598
- Acronym / sponsor ID
- VAI04
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not get IMP
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 18 Feb 2009 (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 see how a combination spray of azelastine and fluticasone (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in allergic rhinitis i.e. does azelastine permit the use of lesser steroid dose (steroid sparing effect) to achieve the same benefit.
Detailed description
Allergic rhinitis (AR) is a major chronic respiratory disease with a prevalence approaching nearly 25% in the worldwide population.Allergic Rhinitis is a common and relatively undiagnosed public health problem and has been reported as being one of the ten most common causes for outpatient attendances to the general practitioner. Long term untreated allergic rhinitis may lead on to asthma. When exposed to allergens (pollen, house dust mite etc) in the atmosphere, the mast cells in the nose burst and an inflammatory response is triggered and patients experience sneezing, itching, blocked nose and running. These allergens may be used as provocation agents to recreate the disease symptoms to confirm the diagnosis of which allergens one is allergic to. However, there is a risk of allergic reactions in doing so. Adenosine monophosphate (AMP)achieves the same goal by stimulating the mast cells and causing them to burst without actually the risks of allergen provocation tests. Such tests are now commonplace in research and clinical medicine. Nasal steroids are considered to be the most potent medications for allergic rhinitis, particularly nasal blockage. Nasal antihistamines are also available but they act mainly to limit nasal running, itching and sneezing and have lesser effect on blockage. The other advantage is that they act very quickly while steroids take at least 72 hours to begin acting and weeks to achieve maximal benefit. Finally, they are free of significant short and long term side effects. Having said that nasal steroids are very safe and unlike inhaled or oral steroids have not been shown to cause systemic side effects in adults. Therefore, it is interesting to see if a combination of an antihistamine and nasal steroid would add their good qualities mentioned above and by the act of reducing the dose of steroid reduce their side effects. To do this we will use nasal AMP challenge as an outcome measure as we have done research studies for over a decade with. We will look at noninvasive nasal airflow parameters, nasal nitric oxide levels, and for safety we will look at the overnight urinary cortisol and creatinine ratio which is the most sensitive and noninvasive test of urine to quantify how much steroid has been absorbed in the blood stream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azelastine Fluticasone | Experimental | Drug: Azelastine , fluticasone |
| Fluticasone propionate | Active comparator | Drug: Fluticasone propionate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male of Female aged 18-65 years.
- Persistent allergic rhinitis with or without asthma.
- Atopy to at least one allergen on SPT.
- Ability to give a written informed consent.
- Ability and willingness to comply with the requirements of the protocol.
Key exclusion criteria (6 listed)
- Recent respiratory tract/sinus infection within the last 2 months. .
- Pregnancy, planned pregnancy or lactation.
- Known or suspected hypersensitivity to any of the IMP's.
- Concomitant use of medicines (prescribed, OTC or herbal) like alpha blockers that may interfere with the trial.
- Nasal Polyposis grade 2+, Deviated nasal septum ≥ 50%
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 |
|---|---|---|
| Azelastine , fluticasoneAzelastine Hydrochloride BP 0.10% w/v AND Fluticasone propionate BP 0.0357% w/v as combination 1 squirt in each nostril twice daily | Drug | Azelastine Fluticasone |
| Fluticasone propionateFluticasone propionate 0.05% w/w 2 squirts in each nostril (50 μg per squirt) | Drug | Fluticasone propionate |
Primary outcome
Maximum percentage fall in PNIF after 400mg/ml of AMP nasal challenge between both groups.
Time frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
6 secondary outcomes
60 minute recovery to AMP challenge
Time frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Mini RQLQ
Time frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Global visual analogue scale
Time frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Nasal lavage for cytokines
Time frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Overnight urinary cortisol creatinine ratio
Time frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Domiciliary diary cards
Time frame: 2 week treatment periods
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2012.
- Background: PubMed 11707753Bousquet J, Van Cauwenberge P, Khaltaev N; Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001 Nov;108(5 Suppl):S147-334. doi: 10.1067/mai.2001.118891. No abstract available.
- Background: PubMed 17265594Nassef M, Shapiro G, Casale TB; Respiratory and Allergic Disease Foundation. Identifying and managing rhinitis and its subtypes: allergic and nonallergic components--a consensus report and materials from the Respiratory and Allergic Disease Foundation. Curr Med Res Opin. 2006 Dec;22(12):2541-8. doi: 10.1185/030079906x158057.
- Background: PubMed 16005621Nolte H, Nepper-Christensen S, Backer V. Unawareness and undertreatment of asthma and allergic rhinitis in a general population. Respir Med. 2006 Feb;100(2):354-62. doi: 10.1016/j.rmed.2005.05.012. Epub 2005 Jul 11.
- Background: PubMed 15080802Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
- Background: PubMed 9848901Weiner JM, Abramson MJ, Puy RM. Intranasal corticosteroids versus oral H1 receptor antagonists in allergic rhinitis: systematic review of randomised controlled trials. BMJ. 1998 Dec 12;317(7173):1624-9. doi: 10.1136/bmj.317.7173.1624.
- Background: PubMed 7908778Meltzer EO, Weiler JM, Dockhorn RJ, Widlitz MD, Freitag JJ. Azelastine nasal spray in the management of seasonal allergic rhinitis. Ann Allergy. 1994 Apr;72(4):354-9.
- Background: PubMed 9195148Newson-Smith G, Powell M, Baehre M, Garnham SP, MacMahon MT. A placebo controlled study comparing the efficacy of intranasal azelastine and beclomethasone in the treatment of seasonal allergic rhinitis. Eur Arch Otorhinolaryngol. 1997;254(5):236-41. doi: 10.1007/BF00874095.
- Background: PubMed 10400480Berger WE, Fineman SM, Lieberman P, Miles RM. Double-blind trials of azelastine nasal spray monotherapy versus combination therapy with loratadine tablets and beclomethasone nasal spray in patients with seasonal allergic rhinitis. Rhinitis Study Groups. Ann Allergy Asthma Immunol. 1999 Jun;82(6):535-41. doi: 10.1016/s1081-1206(10)63161-4.
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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.
Sriram Vaidyanathan, MBBS principal investigator
University of Dundee
Brian Lipworth, MD, FRCP study director
University of Dundee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azelastine , fluticasone and Fluticasone propionate in people with Allergic Rhinitis, run by University of Dundee at 2 sites 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Maximum percentage fall in PNIF after 400mg/ml of AMP nasal challenge between both groups. (time frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 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 NCT00845598, which also lists 8 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 12 Jun 2012; AzTrials last refreshed its copy on 28 Oct 2026.