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

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fenoterol MDI
DSCG MDI
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fenoterol metered dose inhaler (MDI)

    DSCG MDI

    Arm Description

    Outcomes

    Primary Outcome Measures

    Airway resistance (Raw)
    Number of binding sites of the β2 receptors per lymphocytes (BS/LY)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2014
    Last Updated
    July 17, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02177370
    Brief Title
    Effect on Fenoterol Metered Dose Inhaler on the Beta-receptor Population on Lymphocytes in Patients With Bronchial Asthma
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Terminated
    Study Start Date
    February 1990 (undefined)
    Primary Completion Date
    October 1996 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fenoterol metered dose inhaler (MDI)
    Arm Type
    Experimental
    Arm Title
    DSCG MDI
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Fenoterol MDI
    Intervention Type
    Drug
    Intervention Name(s)
    DSCG MDI
    Primary Outcome Measure Information:
    Title
    Airway resistance (Raw)
    Time Frame
    after 2 weeks
    Title
    Number of binding sites of the β2 receptors per lymphocytes (BS/LY)
    Time Frame
    after 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

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

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