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

NCT ID: NCT02177370

Last Updated: 2014-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

1990-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Fenoterol metered dose inhaler (MDI)

Group Type EXPERIMENTAL

Fenoterol MDI

Intervention Type DRUG

DSCG MDI

Group Type ACTIVE_COMPARATOR

DSCG MDI

Intervention Type DRUG

Interventions

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Fenoterol MDI

Intervention Type DRUG

DSCG MDI

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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260.716

Identifier Type: -

Identifier Source: org_study_id

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