A Study of the Effects of Single Dose Corticosteroids on Response to Allergens

A Phase 1 study testing prednisone in people with Allergic Rhinitis, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Allergic Rhinitis
What is being tested?: prednisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: No sites listed yet
Study dates: 4 Feb 2009to 21 May 2009
Phase: Phase 1
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patient is allergic to Timothy grass pollen
Female patients have a negative pregnancy test and agree to use birth control throughout the study
Male patients agree to use birth control throughout the study
Patient has been a nonsmoker for at least 6 months
Patient agrees to avoid the use of aspirin and other Non-steroidal anti-inflammatory drugs (NSAIDs) throughout study

Who cannot join

Patient is breastfeeding
Patient has any respiratory disease other than mild stable asthma that does not require treatment
Patient consumes more than 3 alcoholic beverages per day
Patient consumes more than 6 caffeinated beverages per day
Patient has had major surgery or has donated or lost 1 unit of blood within 4 weeks of screening
Patient has severe allergies

About this study

Official title: A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients

Conditions: Allergic Rhinitis
Being tested: Placebo, prednisone
Medical subject headings: Rhinitis, Allergic

What participants receive

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

PlaceboDrug
Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks
prednisoneDrug
Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
prednisoneDrug
Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.

Study groups in NCT00828061
Study group	Role	What they receive
A	Placebo comparator	placebo Receives: Drug: Placebo
B	Active comparator	10 mg prednisone Receives: Drug: prednisone
C	Active comparator	25 mg prednisone Receives: Drug: prednisone

What is being measured

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

Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration
Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo
Measured: Baseline and Hour 8 post nasal allergen challenge

Secondary outcomes (1)

Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils
Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo
Measured: Baseline and Hour 8 post nasal allergen challenge

Timeline

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

4 Feb 200921 May 2009

First posted23 Jan 2009 (estimated)
Study start4 Feb 2009
Primary completion7 May 2009
Study completion21 May 2009

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 (1)Papers the sponsor has linked to this study.
Other trials for Allergic RhinitisStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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 1
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00828061
Sponsor's protocol ID: 0000-129
Other IDs: 2009_517
Status last verified: Mar 2019
First submitted: 21 Jan 2009
Last updated: 2 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Leaker BR, Malkov VA, Mogg R, Ruddy MK, Nicholson GC, Tan AJ, Tribouley C, Chen G, De Lepeleire I, Calder NA, Chung H, Lavender P, Carayannopoulos LN, Hansel TT. The nasal mucosal late allergic reaction to grass pollen involves type 2 inflammation (IL-5 and IL-13), the inflammasome (IL-1beta), and complement. Mucosal Immunol. 2017 Mar;10(2):408-420. doi: 10.1038/mi.2016.74. Epub 2016 Sep 28.
PubMed 27677865

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

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom

All Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients
ClinicalTrials.gov ID: NCT00828061
Acronym / sponsor ID: 0000-129
Conditions: Allergic Rhinitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 4 Feb 2009 (actual)
Primary completion: 7 May 2009 (actual)
Study completion: 21 May 2009 (actual)
First posted: 23 Jan 2009 (estimated)
Results: Posted 5 May 2010

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: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
A	Placebo comparator	Drug: Placeboplacebo
B	Active comparator	Drug: prednisone10 mg prednisone
C	Active comparator	Drug: prednisone25 mg prednisone

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Patient is allergic to Timothy grass pollen
Female patients have a negative pregnancy test and agree to use birth control throughout the study
Male patients agree to use birth control throughout the study
Patient has been a nonsmoker for at least 6 months
Patient agrees to avoid the use of aspirin and other Non-steroidal anti-inflammatory drugs (NSAIDs) throughout study

Key exclusion criteria (6 listed)

Patient is breastfeeding
Patient has any respiratory disease other than mild stable asthma that does not require treatment
Patient consumes more than 3 alcoholic beverages per day
Patient consumes more than 6 caffeinated beverages per day
Patient has had major surgery or has donated or lost 1 unit of blood within 4 weeks of screening

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
PlaceboSingle dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks	Drug	A
prednisoneSingle dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks.	Drug	B
prednisoneSingle dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.	Drug	C

Primary outcome

Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration
Time frame: Baseline and Hour 8 post nasal allergen challenge
Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo

1 secondary outcome

Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils
Time frame: Baseline and Hour 8 post nasal allergen challenge

Results and safety

Results posted to the registry on 5 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo / Prednisone / Prednisone	4	4
Prednisone / Prednisone / Placebo	3	3
Prednisone / Placebo / Prednisone	3	3
Placebo / Prednisone / Prednisone	3	3
Prednisone / Placebo / Prednisone	3	3
Prednisone / Prednisone / Placebo	3	3

Primary outcome: Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration

Time frame: Baseline and Hour 8 post nasal allergen challenge. Geometric mean (95% Confidence Interval). Unit: Fold Change

Measure	Placebo n = 19	10 mg Prednisone n = 19	25 mg Prednisone n = 19
Value	26.94 (7.33 to 99.00)	6.70 (1.82 to 24.61)	1.86 (0.51 to 6.83)

Placebo vs 10 mg Prednisone: Geometric Mean Fold Difference: 0.25 (95% CI 0.12 to 0.54), p = 0.002, ANOVA
Placebo vs 25 mg Prednisone: Geometric Mean Fold Difference: 0.07 (95% CI 0.03 to 0.15), p <0.001, ANOVA

Population analysed: All Patients as Treated

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 19 (0%)	12 of 19 (63.2%)	Not reported
10 mg Prednisone	0 of 19 (0%)	8 of 19 (42.1%)	Not reported
25 mg Prednisone	0 of 19 (0%)	8 of 19 (42.1%)	Not reported

Limitations and caveats (from the sponsor): Poor cell yields from nasal lavage significantly reduced the utility of eosinophil count data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27677865Leaker BR, Malkov VA, Mogg R, Ruddy MK, Nicholson GC, Tan AJ, Tribouley C, Chen G, De Lepeleire I, Calder NA, Chung H, Lavender P, Carayannopoulos LN, Hansel TT. The nasal mucosal late allergic reaction to grass pollen involves type 2 inflammation (IL-5 and IL-13), the inflammasome (IL-1beta), and complement. Mucosal Immunol. 2017 Mar;10(2):408-420. doi: 10.1038/mi.2016.74. Epub 2016 Sep 28.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Allergic Rhinitis

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing prednisone in people with Allergic Rhinitis, run by Merck Sharp & Dohme LLC.

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: finished, as of the sponsor's last update on 2 Apr 2019. 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 5 May 2010). 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?

Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration (time frame: Baseline and Hour 8 post nasal allergen challenge). 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 NCT00828061, 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 2 Apr 2019.