NCT00421018

Brief Summary

The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in patients with allergic asthma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

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

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

3.4 years

First QC Date

January 10, 2007

Last Update Submit

August 14, 2012

Conditions

Allergic Asthma

Keywords

AsthmaAllergyCytokinesGlucocorticoidsInflammationNitric Oxide (NO)Quality of LifeSelf-Rated HealthStress

Outcome Measures

Primary Outcomes (1)

  • Mini-AQLQ (Asthma-Related Quality of Life)

    1 year

Study Arms (2)

Symptom-guided group

SHAM COMPARATOR

Anti-inflammatory treatment is guided conventionally according to symptoms and beta-2-agonist use.

Drug: Single corticosteroid inhalers and Singulair

FeNO-guided group

ACTIVE COMPARATOR

Anti-inflammatory treatment is guided according to the level of exhaled nitric oxide

Drug: Single corticosteroid inhalers and Singulair

Interventions

Single corticosteroid inhalers and SingulairDRUG

Treatment steps according to preset algorithm

FeNO-guided groupSymptom-guided group

Eligibility Criteria

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

You may qualify if:

  • Age 18-64
  • Clinical diagnosis of Asthma
  • Glucocorticoid treatment \> 6 months.
  • Verified Allergy
  • Read and speak Swedish

You may not qualify if:

  • Smoking
  • Current regular treatment with long-acting beta2-agonist
  • Treatment with Singulair only or in combination with glucocorticoids
  • Taking part in other research study
  • Pregnancy or breast-feeding
  • Unstable Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Runby Primary Health Care Center

Upplands Vasby, Sweden

Location

MeSH Terms

Conditions

AsthmaHypersensitivityInflammation

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kjell Alving, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 11, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

SE(1)