AsthmaPhase 1NCT00623714

Induced Sputum Study (0000-065)

A Phase 1 study testing Comparator: fluticasone in people with Asthma, 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

The primary goals of this study will be to implement innovative processing and detection assays to qualify induced sputum measurements of markers of allergen-induced airway inflammation. The results of this study are intended to form a platform to be used in the clinical development of novel asthma therapeutics. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Asthma
What is being tested?: Comparator: fluticasone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: No sites listed yet
Study dates: Jan 2008to Mar 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 has a history of mild to moderate persistent allergic asthma for at least 6 months with typical symptoms, including cough, wheezing, and shortness of breath, is clinically stable and has no history of recent respiratory tract infection within 3 weeks of the start of the study
Patient, aside history of asthma, is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests.
Patient is able to perform reproducible pulmonary function test.
Patient has an allergic response to house dust mite allergen, demonstrates a positive early and late phase response to an inhaled allergen challenge (as defined by a bronchoconstrictive response)
Patient is a nonsmoker for at least 12 months. Patients must have less than or equal to 10 pack years of smoking to be included. (10 pack years = one pack per day for 10 years.) Patients who have discontinued smoking for at least 10 months may be enrolled at the discretion of the investigator
Patient is willing to avoid strenuous physical activity (i.e., strenuous or unaccustomed weight lifting, running, bicycling, etc.) for 72 hours prior to each visit when laboratory safety tests are obtained and 48 hours prior to allergen challenge

Who cannot join

Patient has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses additional risk to the patient by their participation in the study
Patient has taken oral corticosteroids within 8 weeks or inhaled corticosteroids/nasal corticosteroids within 4 weeks of screening and/or during the study
Patient has a history of stroke, chronic seizures, or major neurological disorder
Patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory (other than asthma), or genitourinary abnormalities or diseases, or has a history of neoplastic disease
Patient is unable to refrain from or anticipates the use of any medication other than the ones permitted in this study, including prescription and non-prescription drugs or herbal remedies prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit
Patient consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages per day or >21 drink equivalents per week.
Patient consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day

About this study

Official title: A Randomized, Placebo-Controlled, Crossover Study to Assess the Effects of Inhaled Fluticasone on Markers of Inflammation After Allergen Challenge in Patients With Allergic Asthma

Conditions: Asthma
Being tested: Comparator: fluticasone, Placebo
Medical subject headings: Asthma

What participants receive

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

Comparator: fluticasoneDrug
Also called fluticasone
Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
PlaceboDrug
Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.

Study groups in NCT00623714
Study group	Role	What they receive
Arm 1	Experimental	study medication + Pbo Receives: Drug: Comparator: fluticasone; Drug: Placebo
Arm 2	Experimental	Pbo + study medication Receives: Drug: Comparator: fluticasone; Drug: Placebo

What is being measured

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

Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL)
Measured: Baseline and 24 hours post allergen challenge

Secondary outcomes (1)

Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL)
Measured: Baseline and 24 hours post allergen challenge

Timeline

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

Jan 2008Mar 2009

First posted26 Feb 2008 (estimated)
Study startJan 2008
Primary completionFeb 2009
Study completionMar 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.
Other trials for AsthmaStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00623714
Sponsor's protocol ID: 0000-065
Other IDs: 065, 2008_509
Status last verified: Apr 2015
First submitted: 11 Feb 2008
Last updated: 5 May 2015
Results posted: Yes, on ClinicalTrials.gov

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

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled, Crossover Study to Assess the Effects of Inhaled Fluticasone on Markers of Inflammation After Allergen Challenge in Patients With Allergic Asthma
ClinicalTrials.gov ID: NCT00623714
Acronym / sponsor ID: 0000-065
Conditions: Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Feb 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 26 Feb 2008 (estimated)
Results: Posted 22 Jun 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: Comparator: fluticasone, Drug: Placebostudy medication + Pbo
Arm 2	Experimental	Drug: Comparator: fluticasone, Drug: PlaceboPbo + study medication

Who may qualify

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

Key inclusion criteria (6 listed)

Patient has a history of mild to moderate persistent allergic asthma for at least 6 months with typical symptoms, including cough, wheezing, and shortness of breath, is clinically stable and has no history of recent respiratory tract infection within 3 weeks of the start of the study
Patient, aside history of asthma, is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests.
Patient is able to perform reproducible pulmonary function test.
Patient has an allergic response to house dust mite allergen, demonstrates a positive early and late phase response to an inhaled allergen challenge (as defined by a bronchoconstrictive response)
Patient is a nonsmoker for at least 12 months. Patients must have less than or equal to 10 pack years of smoking to be included. (10 pack years = one pack per day for 10 years.) Patients who have discontinued smoking for at least 10 months may be enrolled at the discretion of the investigator

Key exclusion criteria (7 listed)

Patient has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses additional risk to the patient by their participation in the study
Patient has taken oral corticosteroids within 8 weeks or inhaled corticosteroids/nasal corticosteroids within 4 weeks of screening and/or during the study
Patient has a history of stroke, chronic seizures, or major neurological disorder
Patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory (other than asthma), or genitourinary abnormalities or diseases, or has a history of neoplastic disease
Patient is unable to refrain from or anticipates the use of any medication other than the ones permitted in this study, including prescription and non-prescription drugs or herbal remedies prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit

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
Comparator: fluticasoneAlso: fluticasoneTwo puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.	Drug	Arm 1, Arm 2
PlaceboTwo puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.	Drug	Arm 1, Arm 2

Primary outcome

Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL)
Time frame: Baseline and 24 hours post allergen challenge

1 secondary outcome

Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL)
Time frame: Baseline and 24 hours post allergen challenge

Results and safety

Results posted to the registry on 22 Jun 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 Then Fluticasone	6	6
Fluticasone Then Placebo	7	7

Primary outcome: Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL)

Time frame: Baseline and 24 hours post allergen challenge. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	Placebo n = 13	Fluticasone n = 13
Value	2.57 (1.37 to 4.84)	0.87 (0.46 to 1.64)

Placebo vs Fluticasone: Geometric Mean Fold Difference: 0.34 (90% CI 0.16 to 0.70), p = 0.011, 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 13 (0%)	5 of 13 (38.5%)	Not reported
Fluticasone	0 of 13 (0%)	6 of 13 (46.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease

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 Comparator: fluticasone in people with Asthma, 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 6 inclusion and 7 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 5 May 2015. 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. 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 22 Jun 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?

Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL) (time frame: Baseline and 24 hours post 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 NCT00623714.

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 5 May 2015.