NCT01061333

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 asthma

Timeline
Completed

Started Jun 2010

Typical duration for phase_1 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 28, 2012

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

February 1, 2010

Results QC Date

April 26, 2012

Last Update Submit

September 3, 2015

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

  • Change in Forced Expiratory Volume in 1 Second (FEV1)

    Maximal percent drop in FEV1 at 20 minutes post allergen challenge

    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

    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

    Pre-allergen challenge and 20 minutes post allergen challenge

Secondary Outcomes (5)

  • Allergen-induced Changes in Urinary 9P

    Baseline and 2 hours post allergen challenge

  • Allergen-induced Changes in Urinary Leukotriene (LT) E4

    Baseline and 2 hours post allergen challenge

  • Allergen-induced Concentrations of Sputum LTC4

    2 hours post allergen challenge

  • Allergen-induced Concentrations of Sputum LTD4

    2 hours post allergen challenge

  • Allergen-induced Concentrations of Sputum LTE4

    2 hours post allergen challenge

Study Arms (4)

Placebo

EXPERIMENTAL

Placebo

Drug: Placebo

Montelukast

EXPERIMENTAL

Montelukast

Drug: Comparator: Montelukast

Nedocromil

EXPERIMENTAL

Nedocromil

Drug: Nedocromil

Mometasone

EXPERIMENTAL

Mometasone

Drug: Comparator: Mometasone

Interventions

NedocromilDRUG

Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge

Nedocromil
Comparator: MontelukastDRUG

Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge

Also known as: Singulair
Montelukast
Comparator: MometasoneDRUG

Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge

Mometasone
PlaceboDRUG

Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Nedocromilmontelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 3, 2010

Study Start

June 1, 2010

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

September 4, 2015

Results First Posted

May 28, 2012

Record last verified: 2015-09