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Can ectoin sprays and drops soothe hay fever? new study investigates

NCT ID NCT01471184

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether Ectoin allergy nasal spray and eye drops can relieve symptoms of hay fever (runny nose, sneezing, itchy eyes) better than a placebo. 46 adults with ragweed allergies were exposed to pollen in a special chamber. Researchers measured symptom scores and nasal airflow to compare the treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

46 people

The number who actually took part.

Start date

Sep 2009

Finished

Mar 2010

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients must have a clinical history of SAR with seasonal onset and offset of nasal and ocular allergy symptoms at least during each of the last two ragweed allergy seasons. 2. Adults (males and females) aged 18 to 65, inclusive. 3. Patients must have documentation of a positive skin test within 12 months of screening to ragweed or a positive skin prick and/or intradermal test for ragweed allergen at Visit 1. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control for the skin prick test or at least 7 mm larger than the negative control for the intradermal test. 4. Non-pregnant, non-lactating women not of childbearing potential who are post-menopausal \[defined as at least 6 months natural spontaneous amenorrhea\], or are surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Surgical sterility should be supported with clinical documentation. Females must have a confirmed absence of pregnancy according to a negative serum pregnancy test or urine pregnancy test at the times described in Section 11. Female subjects of child bearing potential must agree to use a reliable and highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g. implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partners) during the trial, as judged by the investigator. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. 5. In generally good health on the basis of medical history and physical examination. 6. Willingness to attend all study visits. 7. Capable of following and understanding instructions. 8. Willing and able to provide written informed consent prior to initiation of any study procedures, including initiation of washout of any concomitant medications. Exclusion Criteria: 1. Asthma based on medical history or investigator judgment (stable mild asthmatics may be included). 2. Current smoker and ex-smokers with more than 10 pack years smoking history. One pack year is defined as 20 cigarettes/day for 1 year. Smoking must have been stopped more than 6 months ago 3. History of lower or upper airway infection in the last four weeks prior to screening. 4. Clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based on the clinical estimate of the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, nasal piercing, recent nasal biopsy, nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa within 60 days prior to the Screening Visit. 5. Pregnancy or breastfeeding, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period, or for 30 days following the study period. 6. Currently participating in a clinical trial or has been exposed to an investigational treatment within the 30 days prior to the Screening Visit. 7. A known or suspected hypersensitivity, and/or contraindication to any of the ingredients of the investigational products. 8. History of alcohol or drug abuse, as judged by the investigator, within the two years prior to the Screening Visit. 9. Use of any of the prohibited medications within the identified exclusion periods (see Section 3.2.4) 10. Any acute or chronic disease that, in the opinion of the investigator, would affect the study objectives or subject safety (e.g., Diabetes mellitus type I, malignant neoplasia, chronic renal failure, inflammatory diseases of liver or kidneys, emphysema, bronchiectasis). 11. Any clinically significant (as determined by the investigator) psychiatric and/or psychological disorders, including impairment of cooperation (e.g. alcohol or drug abuse). 12. Patients not able to follow study procedures (e.g. language problems, psychological disorders). 13. Suspected non-compliance to study protocol. Non-compliance is e.g. application of less than 60% (according to post treatment container's weight) or missing more than one application on either of the last two days before EEC.

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Conditions

The condition(s) this trial relates to.

allergic rhinitis atopic conjunctivitis conjunctivitis Conjunctivitis, Allergic Rhinitis, Allergic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cetero Research

    Mississauga, Ontario, L4W 1N2, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.