Phase 4
Completed N=578
Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01397890 ↗Enrolled (actual)
578
Serious AEs
6.6%
Results posted
Aug 2014
Primary outcomePrimary: Pre-dose FEV1 — 1.050; 1.006 Ratio — p=0.0004
Summary
This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-dose FEV1 |
1.050; 1.006 | 0.0004 sig |
| SECONDARY Post-dose FEV1 at 5 Minutes |
1.128; 1.045 | <0.0001 sig |
| SECONDARY Post-dose FEV1 at 60 Minutes |
1.164; 1.072 | <0.0001 sig |
| SECONDARY Pre-dose FVC |
1.032; 1.013 | 0.0570 |
| SECONDARY Post-dose FVC at 5 Minutes |
1.096; 1.044 | <0.0001 sig |
| SECONDARY Post-dose FVC at 60 Minutes |
1.116; 1.059 | <0.0001 sig |
| SECONDARY Pre-dose IC |
1.042; 1.022 | 0.1956 |
| SECONDARY Post-dose IC at 60 Minutes |
1.154; 1.087 | <0.0001 sig |
| SECONDARY Pre-dose PEF in Last Week of Treatment |
15.753; -4.550 | 0.0001 sig |
| SECONDARY Pre-dose PEF in First Week of Treatment |
13.405; -0.182 | <0.0001 sig |
| SECONDARY Pre-dose PEF in Whole Treatment Period |
12.271; -5.198 | <0.0001 sig |
| SECONDARY Post-dose PEF in Last Week of Treatment |
23.379; -3.049 | 0.0001 sig |
| SECONDARY Post-dose PEF in First Week of Treatment |
17.412; 0.220 | 0.0006 sig |
| SECONDARY Post-dose PEF in Whole Treatment Period |
15.880; -2.591 | <0.0001 sig |
| SECONDARY Use of Reliever Medication During Day in the Last Week on Treatment |
-0.750; -0.082 | <0.0001 sig |
| SECONDARY Use of Reliever Medication During Day in the First Week on Treatment |
-0.457; -0.082 | <0.0001 sig |
| SECONDARY Use of Reliever Medication During Day in the Whole Treatment Period |
-0.685; -0.134 | <0.0001 sig |
| SECONDARY Use of Reliever Medication During Night in the Last Week on Treatment |
-0.174; 0.062 | 0.0028 sig |
| SECONDARY Use of Reliever Medication During Night in the First Week on Treatment |
-0.113; 0.011 | 0.0372 sig |
| SECONDARY Use of Reliever Medication During Night in the Whole Treatment Period |
-0.241; -0.010 | 0.0001 sig |
| SECONDARY Change in COPD Symptoms - Breathing |
-0.372; -0.110 | <0.0001 sig |
| SECONDARY Change in COPD Symptoms - Cough |
-0.311; -0.169 | 0.0067 sig |
| SECONDARY Change in COPD Symptoms - Sputum |
-0.216; -0.094 | 0.0171 sig |
| SECONDARY COPD Exacerbations |
0.182; 0.307 | 0.0032 sig |
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent
- Men or women patients ≥40 years of age
- Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
- Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) < 70%, pre-bronchodilator
- Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period
Exclusion Criteria
- A history of asthma and seasonal allergic rhinitis before 40 years of age
- Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in period
- Patients with relevant cardiovascular disorder judged by the investigator
- Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
- Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
Data sourced from ClinicalTrials.gov (NCT01397890). 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.