NCT00711165

Brief Summary

A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
Last Updated

July 8, 2008

Status Verified

July 1, 2008

Enrollment Period

8 months

First QC Date

July 3, 2008

Last Update Submit

July 3, 2008

Conditions

Asthma

Keywords

AsthmaNitric OxideExhaled Breath CondensateMethacholine Challenge

Outcome Measures

Primary Outcomes (1)

  • Exhaled Nitric Oxide

    8 weeks

Secondary Outcomes (1)

  • Airway Reactivity

    8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, 2 puffs, bid

Drug: Placebo

Memetasone

EXPERIMENTAL

Mometasone

Drug: Mometasone Furoate

Interventions

PlaceboDRUG

2 puffs, qd

Placebo
Mometasone FuroateDRUG

400 mcg, qd for 8 weeks

Also known as: asmanex
Memetasone

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Asthma
  • non-smoker
  • FEV1 of at least 60% predicted

You may not qualify if:

  • Pregnancy or lactation
  • Corticosteroid use in past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (1)

  • Mehta V, Stokes JR, Berro A, Romero FA, Casale TB. Time-dependent effects of inhaled corticosteroids on lung function, bronchial hyperresponsiveness, and airway inflammation in asthma. Ann Allergy Asthma Immunol. 2009 Jul;103(1):31-7. doi: 10.1016/S1081-1206(10)60140-8.

    PMID: 19663124DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Thomas B Casale, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 8, 2008

Study Start

August 1, 2005

Primary Completion

April 1, 2006

Study Completion

August 1, 2006

Last Updated

July 8, 2008

Record last verified: 2008-07

Locations

US(1)