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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02177370
• Other study ID #: 260.716
• Status: Terminated
• Phase: Phase 3
• First received: June 24, 2014
• Last updated: July 17, 2014
• Start date: February 1990

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. primary completion date: October 1996
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fenoterol MDI

• DSCG MDI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway resistance (Raw)		after 2 weeks	No
Primary	Number of binding sites of the ß2 receptors per lymphocytes (BS/LY)		after 2 weeks	No

External Links

•   Link