Phase 2
Completed N=2,080
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00528996 ↗
Enrolled (actual)
2,080
Serious AEs
8.9%
Results posted
Aug 2021
Primary outcomePrimary: Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks — -0.034; 0.044; 0.066; 0.087 litre
Summary
The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks |
-0.034; 0.044; 0.066; 0.087; 0.092 | — |
| SECONDARY Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks |
-0.014; 0.070; 0.090; 0.106; 0.097; -0.013 | — |
| SECONDARY Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks |
-0.002; 0.146; 0.172; 0.186; 0.174; -0.002 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks |
0.029; 0.172; 0.186; 0.177; 0.165; 0.021 | — |
| SECONDARY Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks |
0.067; 0.321; 0.336; 0.302; 0.312; 0.050 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks |
0.103; 0.246; 0.260; 0.266; 0.246; 0.090 | — |
| SECONDARY Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks |
0.216; 0.474; 0.478; 0.463; 0.463; 0.186 | — |
| SECONDARY Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point |
1.200; 1.309; 1.310; 1.263; 1.276; 1.206 | — |
| SECONDARY Individual Forced Vital Capacity (FVC) Measurements at Each Time Point |
2.572; 2.787; 2.778; 2.691; 2.729; 2.589 | — |
| SECONDARY Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 |
0.008; 0.060; 0.101; 0.124; 0.103; 0.012 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration |
1.128; 1.195; 1.185; 1.147; 1.206; 1.135 | — |
| SECONDARY Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration |
2.381; 2.530; 2.535; 2.455; 2.500; 2.392 | — |
| SECONDARY Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) |
163.41; 177.03; 176.20; 179.46; 177.54; 164.34 | — |
| SECONDARY Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) |
173.64; 186.40; 186.37; 187.31; 187.13; 173.18 | — |
| SECONDARY Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) |
2.514; 1.964; 1.972; 1.790; 2.084; 2.524 | — |
| SECONDARY Physician's Global Evaluation |
4.4; 4.5; 4.5; 4.4; 4.5; 4.541 | — |
| SECONDARY Transition Dyspnea Index - Functional Impairment Domain Score |
2.3; 2.3; 2.3; 2.2; 2.3; 0.192 | — |
| SECONDARY Transition Dyspnea Index - Magnitude of Task Domain Score |
2.2; 2.2; 2.2; 2.2; 2.2; 0.245 | — |
| SECONDARY Transition Dyspnea Index - Magnitude of Effort Domain Score |
2.1; 2.0; 2.0; 2.0; 2.0; 0.161 | — |
| SECONDARY St. George's Respiratory Questionnaire (SGRQ) Total Score |
43.2; 41.9; 42.5; 43.8; 43.1; 41.969 | — |
| SECONDARY 36-item-health Survey (SF-36) 8 Domain Scores at Baseline |
50.2; 51.4; 51.9; 49.1; 51.1; 53.9 | — |
| SECONDARY 36-item-health Survey (SF-36) - Physical Function Domain Score |
50.201; 51.831; 52.812; 52.961; 53.052; 50.541 | — |
| SECONDARY 36-item-health Survey (SF-36) - Role Physical Domain Score |
55.168; 57.326; 57.469; 56.898; 57.950; 54.405 | — |
| SECONDARY 36-item-health Survey (SF-36) - Bodily Pain Domain Score |
66.828; 68.184; 70.738; 66.439; 70.512; 66.749 | — |
| SECONDARY 36-item-health Survey (SF-36) - General Physical Health Domain Score |
47.187; 48.725; 50.929; 49.476; 50.609; 46.709 | — |
| SECONDARY 36-item-health Survey (SF-36) - Vitality Domain Score |
52.501; 53.516; 54.084; 53.630; 54.881; 51.676 | — |
| SECONDARY 36-item-health Survey (SF-36) - Social Functioning Domain Score |
75.574; 76.235; 76.418; 77.177; 77.053; 73.093 | — |
| SECONDARY 36-item-health Survey (SF-36) - Role Emotional Domain Score |
69.365; 70.509; 70.473; 71.646; 71.313; 67.399 | — |
| SECONDARY 36-item-health Survey (SF-36) - General Mental Health Domain Score |
69.585; 71.056; 70.927; 71.038; 71.281; 69.201 | — |
| SECONDARY Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
85; 60; 77; 57; 73 | — |
| SECONDARY Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
0.5797; 0.4345; 0.4898; 0.4373; 0.5332 | — |
Eligibility Criteria
Inclusion Criteria
- All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
- All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) <80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).
- Male or female patients 40 years of age or older.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
- Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
- Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)
Exclusion Criteria
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
- Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
- Patients with a recent history (one year or less) of myocardial infarction.
- Patients with any unstable or life-threatening cardiac arrhythmia.
- Patients who have been hospitalized for heart failure within the past 3 years.
- Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
- Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
- Patients with known narrow-angle glaucoma.
- Patients with asthma or a history of asthma.
- Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
- Patients with known active tuberculosis.
- Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
Data sourced from ClinicalTrials.gov (NCT00528996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.