NCT02177370

Brief Summary

The aim of the study was to compare the effect of fenoterol metered dose inhaler with disodium cromoglycate (DSCG) metered dose inhaler on the lymphocyte β2-receptor population as well as on the clinical findings in patients with bronchial asthma over a two-week period of treatment.

Trial Health

10
At Risk

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_3 asthma

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1990

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1996

Completed
17.7 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
Last Updated

July 18, 2014

Status Verified

June 1, 2014

Enrollment Period

6.7 years

First QC Date

June 24, 2014

Last Update Submit

July 17, 2014

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • Airway resistance (Raw)

    after 2 weeks

  • Number of binding sites of the β2 receptors per lymphocytes (BS/LY)

    after 2 weeks

Study Arms (2)

Fenoterol metered dose inhaler (MDI)

EXPERIMENTAL
Drug: Fenoterol MDI

DSCG MDI

ACTIVE COMPARATOR
Drug: DSCG MDI

Interventions

Fenoterol MDIDRUG
Fenoterol metered dose inhaler (MDI)
DSCG MDIDRUG
DSCG MDI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sex: male and female
  • age: 18 years or over
  • bronchial asthma, diagnosis confirmed by history and positive inhalation challenge test (unspecific challenge with carbachol, PD100SRaw))
  • severity of asthma mild to moderate or asthmatic in symptom-free intervals
  • Raw ≤ 5 cm H2O/l/s
  • no antiasthmatic treatment in the week (steroid therapy: two weeks) before the start of the study

You may not qualify if:

  • clinically significant, concomitant haematological, cardiac, renal, hepatic or metabolic diseases
  • intercurrent diseases, e.g. severe respiratory infections
  • patients who cannot do without the following preparations during the 5-week trial:
  • inhaled/oral steroids
  • theophylline
  • antihistamine, antiallergic drugs
  • inhaled/oral sympathomimetics
  • anticholinergics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 27, 2014

Study Start

February 1, 1990

Primary Completion

October 1, 1996

Last Updated

July 18, 2014

Record last verified: 2014-06