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

Boehringer Ingelheim

Status and phase: Terminated; Phase 3

Conditions: Asthma

Treatments: Drug: DSCG MDI; Drug: Fenoterol MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02177370

260.716

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

19 participants in 2 patient groups

Fenoterol metered dose inhaler (MDI)

Experimental group

Treatment:

Drug: Fenoterol MDI

DSCG MDI

Active Comparator group

Treatment:

Drug: DSCG MDI