Effect on Fenoterol Metered Dose Inhaler on the Beta-receptor Population on Lymphocytes in Patients With Bronchial Asthma

July 17, 2014 updated by: Boehringer Ingelheim

Effect of Fenoterol Metered Dose Inhaler (0.1 mg) on the Beta-receptor Population on Lymphocytes and the Clinical Findings Compared With Treatment With DSCG Metered Dose Inhaler in Patients With Bronchial Asthma.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fenoterol metered dose inhaler (MDI)
Drug: Fenoterol MDI
Active Comparator: DSCG MDI
Drug: DSCG MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Airway resistance (Raw)
Time Frame: after 2 weeks
after 2 weeks
Number of binding sites of the β2 receptors per lymphocytes (BS/LY)
Time Frame: after 2 weeks
after 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1990

Primary Completion (Actual)

October 1, 1996

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260.716

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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