Rhinitis, AllergicPhase 2/3NCT00770315

Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234)

A Phase 2/3 study testing Ambrosia artemisiifolia allergen extract (Amb a 1-U) in people with Rhinitis, Allergic and Conjunctivitis, run by ALK-Abelló A/S.

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

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Rhinitis, Allergic, Conjunctivitis
What is being tested?: Ambrosia artemisiifolia allergen extract (Amb a 1-U)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 784 participants
Where: No sites listed yet
Study dates: Sep 2009to May 2011
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Must have a clinical history of significant ragweed-induced allergic rhinoconjunctivitis of at least 2 years duration, with or without asthma and have received treatment during the previous ragweed season (RS).
Must have a positive skin prick test response to Ambrosia artemisiifolia at Screening Visit.
Must be positive for specific immunoglobulin E (IgE) against Ambrosia artemisiifolia at Screening Visit.
Must have an forced expiratory volume in one second (FEV1) of at least 70% of predicted at Screening Visit.
Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor.
Must be willing to give written informed consent and be able to adhere to dose and visit schedules.

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Female participants of childbearing potential must be using a medically acceptable and adequate form of birth control. These include: hormonal contraceptives as prescribed by a physician (oral, hormonal vaginal ring, hormonal implant or depot injectable); medically prescribed intra-uterine device; medically prescribed topically-applied transdermal contraceptive patch; double-barrier method (eg, condom in combination with a spermicide).
Female participants of childbearing potential should be counseled in the appropriate use of birth control while in the study. Female participants who are not currently sexually active must and consent to use one of the above-mentioned methods if she becomes sexually active during the study.
Female participants of childbearing potential must have a negative urine pregnancy test at Screening Visit. Women who have been surgically sterilized or at least 1 year postmenopausal are not considered to be of childbearing potential.

Who cannot join

Clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another during or potentially overlapping the RS.
Clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed.
Receipt of an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
Clinical history of severe asthma.
Asthma requiring medium or high dose inhaled corticosteroids (ICS).
History of anaphylaxis with cardiorespiratory symptoms.

Show all 24Show fewer

History of chronic urticaria and angioedema.
Clinical history of chronic sinusitis 2 years prior to the Screening Visit.
Current severe atopic dermatitis.
Breast-feeding, pregnancy, or intending to become pregnant.
Had previous treatment by immunotherapy with ragweed allergen or any other allergen 5 years prior to Screening Visit.
History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (except for Ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine.
Any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
Use of any investigational drugs within 30 days of Screening Visit.
Participation in any other clinical study.
Being a family member of the study staff.
Inability to meet medication washout requirements.
Unlikely to be able to complete the trial, or likely to travel for an extended time during the RS.
Clinically significant abnormal vital sign or lab value.
Participation in this same study at another site.
Randomized into this study more than once.
Inability to or will not comply with the use of self-injectable epinephrine.
Greater risk of developing adverse reactions after epinephrine administration.
History of self-injectable epinephrine use

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma

This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641/Amb a 1-U) compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and require less allergy rescue medications during ragweed pollen season.

Conditions: Rhinitis, Allergic, Conjunctivitis
Being tested: Ambrosia artemisiifolia allergen extract (Amb a 1-U), Placebo
Medical subject headings: Rhinitis, Allergic, Conjunctivitis

What participants receive

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

Ambrosia artemisiifolia allergen extract (Amb a 1-U)Biological
Also called SCH 39641, MK-3641
Rapidly dissolving tablet administered sublingually once daily, at a dose of 1.5, 6 or 12 units.
PlaceboBiological
Placebo matching Ambrosia artemisiifolia allergen extract rapidly dissolving tablet, administered sublingually once daily

Study groups in NCT00770315
Study group	Role	What they receive
SCH 39641 1.5 Amb a 1-U	Experimental	Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks Receives: Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)
SCH 39641 6 Amb a 1-U	Experimental	Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks Receives: Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)
SCH 39641 12 Amb a 1-U	Experimental	Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks Receives: Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)
Placebo	Placebo comparator	Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks Receives: Biological: Placebo

What is being measured

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

Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)
The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.
Measured: The 15-day period during the ragweed season with the highest moving pollen average

Secondary outcomes (4)

Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS
The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.
Measured: Approximately 5 weeks
Average Rhinoconjunctivitis DSS for the Peak RS
The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.
Measured: The 15-day period during the ragweed season with the highest moving pollen average
Average Rhinoconjunctivitis DSS for the Entire RS
The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.
Measured: Approximately 5 weeks
Average Rhinoconjunctivitis DMS for the Peak RS
Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.
Measured: The 15-day period during the ragweed season with the highest moving pollen average

Timeline

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

Sep 2009May 2011

First posted10 Oct 2008 (estimated)
Study startSep 2009
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Rhinitis, AllergicStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 784 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00770315
Sponsor's protocol ID: P05234
Other IDs: 3810249, 2008-003864-20, MK-3641-002, 2008
Status last verified: Jan 2017
First submitted: 9 Oct 2008
Last updated: 3 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Creticos PS, Maloney J, Bernstein DI, Casale T, Kaur A, Fisher R, Liu N, Murphy K, Nekam K, Nolte H. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. J Allergy Clin Immunol. 2013 May;131(5):1342-9.e6. doi: 10.1016/j.jaci.2013.03.019.
PubMed 23622121
Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21.
PubMed 26507708
Kim H, Waserman S, Hebert J, Blaiss M, Nelson H, Creticos P, Kaur A, Maloney J, Li Z, Nolte H. Efficacy and safety of ragweed sublingual immunotherapy in Canadian patients with allergic rhinoconjunctivitis. Allergy Asthma Clin Immunol. 2014 Nov 10;10(1):55. doi: 10.1186/1710-1492-10-55. eCollection 2014.
PubMed 25788949
Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hebert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14.
PubMed 24836393

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma
ClinicalTrials.gov ID: NCT00770315
Acronym / sponsor ID: P05234
Conditions: Rhinitis, Allergic, Conjunctivitis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 784 participants (actual)
Lead sponsor: ALK-Abelló A/SIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 10 Oct 2008 (estimated)
Results: Posted 3 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
SCH 39641 1.5 Amb a 1-U	Experimental	Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
SCH 39641 6 Amb a 1-U	Experimental	Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
SCH 39641 12 Amb a 1-U	Experimental	Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
Placebo	Placebo comparator	Biological: PlaceboParticipants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Must have a clinical history of significant ragweed-induced allergic rhinoconjunctivitis of at least 2 years duration, with or without asthma and have received treatment during the previous ragweed season (RS).
Must have a positive skin prick test response to Ambrosia artemisiifolia at Screening Visit.
Must be positive for specific immunoglobulin E (IgE) against Ambrosia artemisiifolia at Screening Visit.
Must have an forced expiratory volume in one second (FEV1) of at least 70% of predicted at Screening Visit.
Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor.

Key exclusion criteria (24 listed)

Clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another during or potentially overlapping the RS.
Clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed.
Receipt of an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
Clinical history of severe asthma.
Asthma requiring medium or high dose inhaled corticosteroids (ICS).

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
Ambrosia artemisiifolia allergen extract (Amb a 1-U)Also: SCH 39641, MK-3641Rapidly dissolving tablet administered sublingually once daily, at a dose of 1.5, 6 or 12 units.	Biological	SCH 39641 1.5 Amb a 1-U, SCH 39641 12 Amb a 1-U, SCH 39641 6 Amb a 1-U
PlaceboPlacebo matching Ambrosia artemisiifolia allergen extract rapidly dissolving tablet, administered sublingually once daily	Biological	Placebo

Primary outcome

Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)
Time frame: The 15-day period during the ragweed season with the highest moving pollen average
The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.

4 secondary outcomes

Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS
Time frame: Approximately 5 weeks
Average Rhinoconjunctivitis DSS for the Peak RS
Time frame: The 15-day period during the ragweed season with the highest moving pollen average
Average Rhinoconjunctivitis DSS for the Entire RS
Time frame: Approximately 5 weeks
Average Rhinoconjunctivitis DMS for the Peak RS
Time frame: The 15-day period during the ragweed season with the highest moving pollen average

Results and safety

Results posted to the registry on 3 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SCH 39641 1.5 Amb a 1-U	197	157
SCH 39641 6 Amb a 1-U	195	152
SCH 39641 12 Amb a 1-U	194	137
Placebo	198	160

Primary outcome: Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)

Time frame: The 15-day period during the ragweed season with the highest moving pollen average. Mean (Standard Error). Unit: score on a scale

Measure	SCH 39641 1.5 Amb a 1-U n = 169	SCH 39641 6 Amb a 1-U n = 167	SCH 39641 12 Amb a 1-U n = 152	Placebo n = 169
Value	7.70 (0.517)	6.88 (0.526)	6.41 (0.534)	8.46 (0.535)

SCH 39641 1.5 Amb a 1-U vs Placebo: Mean Difference (Final Values): -0.76 (95% CI -1.98 to 0.45), p = 0.2192, ANOVA
SCH 39641 6 Amb a 1-U vs Placebo: Mean Difference (Final Values): -1.58 (95% CI -2.80 to -0.36), p = 0.0113, ANOVA
SCH 39641 12 Amb a 1-U vs Placebo: Mean Difference (Final Values): -2.04 (95% CI -3.30 to -0.79), p = 0.0015, ANOVA

Population analysed: The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 53 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SCH 39641 1.5 Amb a 1-U	5 of 196 (2.6%)	105 of 196 (53.6%)	Not reported
SCH 39641 6 Amb a 1-U	4 of 195 (2.1%)	108 of 195 (55.4%)	Not reported
SCH 39641 12 Amb a 1-U	4 of 194 (2.1%)	125 of 194 (64.4%)	Not reported
Placebo	1 of 198 (0.5%)	78 of 198 (39.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23622121Creticos PS, Maloney J, Bernstein DI, Casale T, Kaur A, Fisher R, Liu N, Murphy K, Nekam K, Nolte H. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. J Allergy Clin Immunol. 2013 May;131(5):1342-9.e6. doi: 10.1016/j.jaci.2013.03.019.
Derived from this study: PubMed 26507708Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21.
Derived from this study: PubMed 25788949Kim H, Waserman S, Hebert J, Blaiss M, Nelson H, Creticos P, Kaur A, Maloney J, Li Z, Nolte H. Efficacy and safety of ragweed sublingual immunotherapy in Canadian patients with allergic rhinoconjunctivitis. Allergy Asthma Clin Immunol. 2014 Nov 10;10(1):55. doi: 10.1186/1710-1492-10-55. eCollection 2014.
Derived from this study: PubMed 24836393Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hebert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ambrosia artemisiifolia allergen extract (Amb a 1-U) in people with Rhinitis, Allergic and Conjunctivitis, run by ALK-Abelló A/S.

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 9 inclusion and 24 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS) (time frame: The 15-day period during the ragweed season with the highest moving pollen average). 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 NCT00770315, which also lists 4 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 3 Mar 2017.