Phase 2
Completed N=206
A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma
Source: ClinicalTrials.gov NCT01311661 ↗Enrolled (actual)
206
Serious AEs
0.7%
Results posted
May 2014
Primary outcomePrimary: Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period — 0.022; 0.213; 0.173; 0.250 Liter — p=<0.0001
Summary
This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period |
0.022; 0.213; 0.173; 0.250; 0.231 | <0.0001 sig |
| SECONDARY FEV1 Area Under Curve 0-12 Hours (AUC 0-12h) Response at the End of Each Treatment Period |
0.052; 0.242; 0.212; 0.266; 0.272 | <0.0001 sig |
| SECONDARY FEV1 Area Under Curve 12-24 Hours (AUC 12-24h) Response at the End of Each Treatment Period |
-0.010; 0.186; 0.135; 0.233; 0.189 | <0.0001 sig |
| SECONDARY Peak FEV1 Within 24 Hours Post-dose Response |
0.227; 0.410; 0.380; 0.449; 0.437 | <0.0001 sig |
| SECONDARY Trough FEV1 Response |
0.033; 0.189; 0.134; 0.229; 0.205 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response |
-0.004; 0.132; 0.119; 0.138; 0.143 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response |
-0.056; 0.102; 0.081; 0.114; 0.079 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response |
-0.029; 0.116; 0.099; 0.127; 0.111 | <0.0001 sig |
| SECONDARY Peak FVC Within 24 Hours Post-dose Response |
0.246; 0.382; 0.371; 0.390; 0.373 | <0.0001 sig |
| SECONDARY Trough FVC Response |
-0.013; 0.096; 0.079; 0.105; 0.098 | 0.0001 sig |
| SECONDARY Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response |
0.101; 0.730; 0.703; 0.732; 0.787 | <0.0001 sig |
| SECONDARY PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response |
-0.135; 0.530; 0.430; 0.567; 0.464 | <0.0001 sig |
| SECONDARY Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response |
-0.014; 0.627; 0.563; 0.653; 0.629 | <0.0001 sig |
| SECONDARY Peak PEF Within 24 Hours Post-dose Response |
0.663; 1.254; 1.185; 1.257; 1.286 | <0.0001 sig |
| SECONDARY Trough PEF Response |
-0.009; 0.520; 0.401; 0.594; 0.472 | <0.0001 sig |
| SECONDARY Mean Pre-dose Morning PEF (PEF a.m.) |
395.36; 428.32; 427.99; 427.02; 424.26 | <0.0001 sig |
| SECONDARY Mean Pre-dose Evening PEF (PEF p.m.) |
409.93; 438.80; 441.98; 441.74; 443.25 | <0.0001 sig |
| SECONDARY PEF Daily Variability |
10.157; 8.576; 8.732; 8.419; 9.468 | <0.0001 sig |
| SECONDARY Mean Pre-dose Morning FEV1 (FEV1 a.m.) |
2425.1; 2598.5; 2580.2; 2574.3; 2575.5 | <0.0001 sig |
| SECONDARY Mean Pre-dose Evening FEV1 (FEV1 p.m.) |
2474.3; 2616.6; 2606.5; 2616.5; 2631.7 | <0.0001 sig |
| SECONDARY Mean Number of Puffs of Rescue Medication During the Whole Day |
1.665; 1.110; 1.028; 1.077; 1.119 | <0.0001 sig |
| SECONDARY Percentage of Asthma Symptom Free Days |
23.630; 33.929; 36.306; 28.844; 28.049 | — |
| SECONDARY Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall) |
93; 50; 53; 44; 47; 67 | — |
| SECONDARY Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall) |
31; 24; 27; 18; 20; 66 | — |
| SECONDARY Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall) |
39; 32; 29; 21; 21; 76 | — |
| SECONDARY Total Asthma Control Questionnaire (ACQ) Score |
1.613; 1.256; 1.317; 1.312; 1.311 | <0.0001 sig |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG |
0; 0; 1; 0; 0; 1 | — |
Eligibility Criteria
Inclusion criteria
- Patients of either sex.
- Aged 18 to 70 years.
- A current diagnosis and a documented minimum 3 month history of asthma Global Initiative for Asthma (GINA) treatment steps 3 and 4.
- Prebronchodilator Forced Expiratory Volume in one second (FEV1) >= 60% predicted and =12% and >=200 mL 15 min. after 400 µg salbutamol (albuterol);
- Stable on medium to high dose inhaled corticosteroids (ICS) or low to high dose ICS in combination with a long acting beta-adrenergics (LABA) for at least 6 weeks prior to screening. Stable on ICS mono component of the former fixed LABA/ICS treatment for at least 48 hours prior to Visit 1b.
Exclusion criteria
- Patients with a significant disease other than asthma.
- History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years).
- Upper respiratory tract infection in the past 3 weeks prior to screening visit 1b.
- Oral or other systemic corticosteroids in the past 6 weeks.
- Patients with allergen desensitization therapy if started within two years, if they are not on an established maintenance regimen characterized by dose adjustments but no further increase to the tolerable maximum in the same course of immunotherapy.
Data sourced from ClinicalTrials.gov (NCT01311661). 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.