AsthmaPhase 1NCT01061333

Early Airway Response to Allergen in Asthmatics (MK-0000-176)

A Phase 1 study testing Nedocromil, Comparator: Montelukast and Comparator: Mometasone 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.

Official record

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Trial summary

This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Asthma
What is being tested?: Nedocromil, Comparator: Montelukast and Comparator: Mometasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: No sites listed yet
Study dates: Jun 2010to Mar 2011
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

History of mild to moderate Asthma
In good general health (except for asthma)
Stable and free of respiratory infection
Nonsmoker
Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)

Who cannot join

Nursing mother
Recent or ongoing upper or lower respiratory tract infection
Unable to refrain from or anticipates the use of any prescription and non-prescription drugs
Consumes excessive amounts of alcohol or caffeine
History of stroke, chronic seizures, or major neurological disorder
History of cancer
Received a vaccination within the past 3 weeks

About this study

Official title: A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics

Conditions: Asthma
Being tested: Nedocromil, Comparator: Montelukast, Comparator: Mometasone, Placebo
Medical subject headings: Asthma

What participants receive

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

NedocromilDrug
Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge
Comparator: MontelukastDrug
Also called Singulair
Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge
Comparator: MometasoneDrug
Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge
PlaceboDrug
Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet

Study groups in NCT01061333
Study group	Role	What they receive
Placebo	Experimental	Placebo Receives: Drug: Placebo
Montelukast	Experimental	Montelukast Receives: Drug: Comparator: Montelukast
Nedocromil	Experimental	Nedocromil Receives: Drug: Nedocromil
Mometasone	Experimental	Mometasone Receives: Drug: Comparator: Mometasone

What is being measured

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

Change in Forced Expiratory Volume in 1 Second (FEV1)
Maximal percent drop in FEV1 at 20 minutes post allergen challenge
Measured: Pre-allergen challenge and 20 minutes after allergen challenge
Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes
Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge
Measured: Pre-allergen challenge and 5 minutes post allergen challenge
Change in Plasma 9P at 20 Minutes
Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge
Measured: Pre-allergen challenge and 20 minutes post allergen challenge

Secondary outcomes (5)

Allergen-induced Changes in Urinary 9P
Fold change over baseline in Urinary 9P at 2 hours post allergen challenge
Measured: Baseline and 2 hours post allergen challenge
Allergen-induced Changes in Urinary Leukotriene (LT) E4
Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge
Measured: Baseline and 2 hours post allergen challenge
Allergen-induced Concentrations of Sputum LTC4
Concentrations of LTC4 in sputum at 2 hours post-allergen challenge
Measured: 2 hours post allergen challenge
Allergen-induced Concentrations of Sputum LTD4
Concentrations of LTD4 in sputum at 2 hours post-allergen challenge
Measured: 2 hours post allergen challenge
Allergen-induced Concentrations of Sputum LTE4
Concentrations of LTE4 in sputum at 2 hours post-allergen challenge
Measured: 2 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.

Jun 2010Mar 2011

First posted3 Feb 2010 (estimated)
Study startJun 2010
Primary completionFeb 2011
Study completionMar 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.
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: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01061333
Sponsor's protocol ID: 0000-176
Other IDs: 2010_507
Status last verified: Sep 2015
First submitted: 1 Feb 2010
Last updated: 4 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
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A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics
ClinicalTrials.gov ID: NCT01061333
Acronym / sponsor ID: 0000-176
Conditions: Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Feb 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 3 Feb 2010 (estimated)
Results: Posted 28 May 2012

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: 4

Arm	Type	Receives
Placebo	Experimental	Drug: PlaceboPlacebo
Montelukast	Experimental	Drug: Comparator: MontelukastMontelukast
Nedocromil	Experimental	Drug: NedocromilNedocromil
Mometasone	Experimental	Drug: Comparator: MometasoneMometasone

Who may qualify

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

Key inclusion criteria (5 listed)

History of mild to moderate Asthma
In good general health (except for asthma)
Stable and free of respiratory infection
Nonsmoker
Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)

Key exclusion criteria (7 listed)

Nursing mother
Recent or ongoing upper or lower respiratory tract infection
Unable to refrain from or anticipates the use of any prescription and non-prescription drugs
Consumes excessive amounts of alcohol or caffeine
History of stroke, chronic seizures, or major neurological disorder

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
NedocromilNedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge	Drug	Nedocromil
Comparator: MontelukastAlso: SingulairMontelukast single 10 mg tablet administered 2 hours prior to allergen challenge	Drug	Montelukast
Comparator: MometasoneMometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge	Drug	Mometasone
PlaceboMometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet	Drug	Placebo

Primary outcome

Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Pre-allergen challenge and 20 minutes after allergen challenge
Maximal percent drop in FEV1 at 20 minutes post allergen challenge
Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes
Time frame: Pre-allergen challenge and 5 minutes post allergen challenge
Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge
Change in Plasma 9P at 20 Minutes
Time frame: Pre-allergen challenge and 20 minutes post allergen challenge
Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge

5 secondary outcomes

Allergen-induced Changes in Urinary 9P
Time frame: Baseline and 2 hours post allergen challenge
Allergen-induced Changes in Urinary Leukotriene (LT) E4
Time frame: Baseline and 2 hours post allergen challenge
Allergen-induced Concentrations of Sputum LTC4
Time frame: 2 hours post allergen challenge
Allergen-induced Concentrations of Sputum LTD4
Time frame: 2 hours post allergen challenge
Allergen-induced Concentrations of Sputum LTE4
Time frame: 2 hours post allergen challenge

Results and safety

Results posted to the registry on 28 May 2012, 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-Montelukast-Nedocromil-Mometasone	8	8
Placebo-Nedocromil-Montelukast-Mometasone	8	8

Primary outcome: Change in Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Pre-allergen challenge and 20 minutes after allergen challenge. Least squares mean (Standard Deviation). Unit: Percentage drop in FEV1

Measure	Placebo n = 16	Nedocromil n = 16	Montelukast n = 15	Mometasone n = 15
Value	-24.66 (10.72)	-8.44 (6.15)	-9.15 (6.96)	-16.17 (11.01)

Placebo vs Nedocromil: Difference in LS mean: 16.22 (90% CI 10.74 to 21.69), p <0.0001, ANCOVA
Placebo vs Montelukast: Difference in LS Mean: 15.51 (90% CI 10.00 to 21.02), p = 0.0001, ANCOVA
Placebo vs Mometasone: Difference in LS Mean: 8.49 (90% CI 1.78 to 15.20), p = 0.0432, ANCOVA

Primary outcome: Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes

Time frame: Pre-allergen challenge and 5 minutes post allergen challenge. Geometric mean (Standard Deviation). Unit: Fold change over baseline

Measure	Placebo n = 16	Nedocromil n = 16	Montelukast n = 15	Mometasone n = 15
Value	0.77 (0.21)	0.97 (0.17)	1.08 (0.44)	1.00 (0.35)

Placebo vs Nedocromil: Geom. Mean Ratio of fold over baseline: 1.27 (90% CI 1.05 to 1.54), p = 0.0430, ANCOVA
Placebo vs Montelukast: Geom. Mean Ratio of fold over baseline: 1.41 (90% CI 1.15 to 1.72), p = 0.0100, ANCOVA
Placebo vs Mometasone: Geom. Mean Ratio of fold over baseline: 1.30 (90% CI 1.01 to 1.67), p = 0.0860, ANCOVA

Primary outcome: Change in Plasma 9P at 20 Minutes

Time frame: Pre-allergen challenge and 20 minutes post allergen challenge. Geometric mean (Standard Deviation). Unit: Fold change over baseline

Measure	Placebo n = 16	Nedocromil n = 16	Montelukast n = 15	Mometasone n = 15
Value	1.22 (0.31)	0.72 (0.25)	0.72 (0.21)	1.06 (0.40)

Placebo vs Nedocromil: Geom. Mean Ratio of fold over baseline: 0.59 (90% CI 0.50 to 0.70), p <0.0001, ANCOVA
Placebo vs Montelukast: Geom. Mean Ratio of fold over baseline: 0.59 (90% CI 0.49 to 0.70), p <0.0001, ANCOVA
Placebo vs Mometasone: Geom. Mean Ratio of fold over baseline: 0.87 (90% CI 0.69 to 1.08), p = 0.2679, ANCOVA

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 16 (0%)	5 of 16 (31.3%)	Not reported
Nedocromil	0 of 16 (0%)	4 of 16 (25%)	Not reported
Montelukast	0 of 15 (0%)	3 of 15 (20%)	Not reported
Mometasone	0 of 15 (0%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nedocromil, Comparator: Montelukast and Comparator: Mometasone 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 5 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 4 Sep 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 28 May 2012). 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?

Change in Forced Expiratory Volume in 1 Second (FEV1) (time frame: Pre-allergen challenge and 20 minutes after allergen challenge). The study lists 3 primary outcomes in all. 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 NCT01061333.

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 4 Sep 2015.