Anticholinergic bronchodilators, such as ipratropium bromide, may be used in combination with beta adrenergic agonists as SAlbutamol to produce bronchodilation in excess of that achieved by either agent alone.Therefore we will treat both study arms with salbutamol. One group A will receive tiotropium bromide with salbutamol, while the other group B will receive salbutamol. MedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Trade Name: Spiriva® 18 Mikrogramm Kapsel mit Inhalationspulver
Product Name: tiotropium bromid
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: TIOTROPIUM ION
CAS Number: 139
Sponsors
Philipps-University Marburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • provided written informed consent • Hospitalized male or female subjects’ = 35 years of age. • Subject who has COPD 2 or 3 according to the GOLD criteria (see Table 1) • FEV1/FVC =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • • Subjects who have taken tiotropium bromide in the last 4 weeks. • Subjects should not have received any mucolytic drug such as acetylcysteine or ambroxol during the study and 24 hours prior to the study. • Subjects who inhale corticosteroids during the time of study; whereas on the day and the day after evaluation inhaled corticosteroids are accepted. • Subject who has suspected or known (positive chest radiograph) pneumonia. • Subject who has suspected or known asthma bronchiale. • Subject who requires parenteral antibiotic therapy. • Subject who has taken: o A systemic antibiotic within 2 weeks before study drug administration o Any long acting antibiotic (e.g., penicillin G benzathine or azithromycin) within 4 weeks before study drug administration. • Subject who has any other infection or condition, which necessitates use of a concomitant systemic antibiotic. • Subject who has a severely compromised respiratory status (i.e., requires continuous oxygen). • Pregnant or breast feeding women • Subjects who are participating in any other clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: is to detect differences in the relative mucin amount between patients with acute exacerbation of COPD treated with tiotropium bromide (Spiriva ®) plus salbutamol and those treated with salbutamol alone.;Secondary Objective: is to investigate the improvement of both the biophysical and transport properties of sputum in patients with acute exacerbation of COPD and the reduction of airway obstruction in the treatment groups. ;Primary end point(s): The primary endpoint of the study is the MUC5AC response. Patients will be considered as responders if their relative amount of MUC5AC, at 42 days after randomization, is equal to the laboratory standard level, a tolerance of +/-15% is permissible. | — |
Countries
Germany
Outcome results
None listed