Seasonal Allergic RhinitisPhase 4MONTASNCT00559546
Montelukast as a Controller of Atopic Syndrome
A Phase 4 study testing montelukast in people with Seasonal Allergic Rhinitis and Allergic Conjunctivitis, run by University of Helsinki at 1 site in Finland.
Trial summary
The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Seasonal Allergic Rhinitis, Allergic Conjunctivitis, Atopic Eczema
- What is being tested?
- montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2007to Jul 2007
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Wheal diameter at least 4 mm in skin-prick test for both birch and timothy
- Allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following:
- Allergic conjunctivitis
- Atopic eczema
- Oral symptoms from vegetables or fruits by cross reactivity to birch
- Urticaria in allergen exposure
Who cannot join
- Need for regular treatment with glucocorticoids
- Current smoking
- Other major disease or need for regular drug treatment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Finland1 site
Skin and Allergy Hospital, Helsinki University Hospital
Helsinki, 00029 HUS
About this study
The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.
- Being tested
- montelukast
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic, Dermatitis, Atopic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukastDrug
10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 3 weeks of Montelukast and 3 weeks of placebo treatment Receives: Drug: montelukast |
| 2 | Active comparator | 3 weeks of placebo and 3 weeks of montelukast treatment Receives: Drug: montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic symptoms
Measured: 3 weeks
Secondary outcomes (2)
Need for antihistamines or inhaled beta-2-agonists to relieve symptoms
Measured: 3 weeks
Exhaled nitric oxide concentration
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startMar 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Tari Haahtela, Professor, Principal investigator, Skin and Allergy Hospital, Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559546
- Sponsor's protocol ID
- HUS7/E5/07
- Acronym
- MONTAS
- Status last verified
- Nov 2007
- First submitted
- 15 Nov 2007
- Last updated
- 16 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Lehtimaki L, Petays T, Haahtela T. Montelukast is not effective in controlling allergic symptoms outside the airways: a randomised double-blind placebo-controlled crossover study. Int Arch Allergy Immunol. 2009;149(2):150-3. doi: 10.1159/000189198. Epub 2009 Jan 6.
PubMed 19127072
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montelukast as a Controller of Atopic Syndrome
- ClinicalTrials.gov ID
- NCT00559546
- Acronym / sponsor ID
- MONTAS / HUS7/E5/07
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Nov 2007 (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 the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: montelukast3 weeks of Montelukast and 3 weeks of placebo treatment |
| 2 | Active comparator | Drug: montelukast3 weeks of placebo and 3 weeks of montelukast treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Wheal diameter at least 4 mm in skin-prick test for both birch and timothy
- Allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following:
Key exclusion criteria (4 listed)
- Need for regular treatment with glucocorticoids
- Current smoking
- Other major disease or need for regular drug treatment
- Pregnancy
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 |
|---|---|---|
| montelukast10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner | Drug | 1, 2 |
Primary outcome
Allergic symptoms
Time frame: 3 weeks
2 secondary outcomes
Need for antihistamines or inhaled beta-2-agonists to relieve symptoms
Time frame: 3 weeks
Exhaled nitric oxide concentration
Time frame: 3 weeks
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 16 Nov 2007.
- Derived from this study: PubMed 19127072Lehtimaki L, Petays T, Haahtela T. Montelukast is not effective in controlling allergic symptoms outside the airways: a randomised double-blind placebo-controlled crossover study. Int Arch Allergy Immunol. 2009;149(2):150-3. doi: 10.1159/000189198. Epub 2009 Jan 6.
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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.
Tari Haahtela, Professor principal investigator
Skin and Allergy Hospital, Helsinki University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing montelukast in people with Seasonal Allergic Rhinitis and Allergic Conjunctivitis, run by University of Helsinki at 1 site in Finland.
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 6 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 16 Nov 2007. 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 Finland. 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?
Allergic symptoms (time frame: 3 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 NCT00559546, which also lists 1 linked publication.
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 Nov 2007.