A one year study of the effect of two drugs (fluticasone propionate and formoterol fumarate) given together compared to either drug given alone, in patients who have a lung disease known as COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease.MedDRA version: 17.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-001916-20-SE
- Lead Sponsor
- Mylan Pharma UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1166
1. Males and females at least 40 years of age. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be using an acceptable, highly effect method of contraception and must also have a negative urine pregnancy test at screening.
2. A clinical diagnosis for at least 6 months prior to screening of COPD according to Global initiative for Obstructive Lung Disease guidelines (GOLD, 2014).
3. History of at least 10 pack-years of tobacco smoking.
4. Spirometry at Visit 1 and Visit 2 following 4 puffs (360 µg) albuterol
pMDI via spacer showing:
a) post-bronchodilator FEV1 =70% of predicted normal (Global Lung
Function Initiative reference range; Quanjer et al, 2012) and,
b) post-bronchodilator FEV1/FVC ratio <0.7
5. Capable of self-administering nebulized study medication, assessed at device training at Visit 1 and as witnessed on self-administered dosing at Visit 1 and Visit 2.
6. Able to understand and complete the study requirements (including literacy, to enable e-diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 583
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 583
1. Current diagnosis of asthma.
2. Alpha-1 anti-trypsin deficiency.
3. Other chronic or active respiratory disorder.
4. Symptoms of, or treatment for an AECOPD requiring antibiotics and/or oral/systemic corticosteroids or in-patient hospitalization during the 28 days preceding screening.
5. Lower respiratory tract infection requiring treatment with antibiotics during the 28 days preceding screening.
6. History or presence of pulmonary hypertension, respiratory failure, cor pulmonale or right ventricular failure.
7. History of pulmonary lobectomy, lung volume reduction surgery, or lung transplantation.
8. Use of supplemental oxygen therapy for more than 12 hours per day (includes night-time use).
9. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the trial.
10. Clinically significant, abnormal chest X-ray at screening indicating an active/significant disease process other than COPD. If a prior chest Xray or thoracic high resolution CT scan within 6 months prior to screening is available this will be acceptable.
11. History of long QT syndrome or screening ECG with QTcF greater than 460 milliseconds.
12. History within past 5 years of paroxysmal atrial fibrillation.Patients with continuous atrial fibrillation controlled with a rate control strategy (i.e., cardioselective ß-blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be included if the ventricular rate is below 100 bpm.
13. Any other clinically significant abnormality on the 12-lead ECG at screening which in the judgment of the investigator would put the patient at potential risk if enrolled into the trial (these patients should not be re-screened).
14. Current evidence of, or history within the 6 months prior to screening of unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, or myocardial infarction.
15. History of malignancy of any organ system treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases. The only exceptions are previous in situ carcinoma of the cervix, localized basal cell carcinoma of the skin or localized squamous carcinoma of the skin if the patient has been treated and is considered cured.
16. Evidence of oropharyngeal candidiasis at screening.
17. Known history of hypothalamic-pituitary-adrenal axis dysfunction.
18. Uncontrolled glaucoma and/or raised IOP within 9 months of screening. Patients with chronic glaucoma will only be considered controlled and eligible for the trial if they have been on stable treatment (unchanged agent and dose) for the prior 9 months and they
have had IOP measurement within this period documented as normal (= 21 mm Hg; documented evidence will be required for eligibility).
19. Patients known to be HIV positive. Specific testing for HIV will not be conducted for this trial.
20. Use of any investigational drug within 28 days, or 5 half lives, prior to screening whichever is longer.
21. Use of medications with the potential to interact with fluticasone propionate, formoterol fumarate (as indicated in the current Investigators' Brochure), albuterol or ipratropium bromide (as indicated in respective product labels), or medications with the potential to affect or confound COPD disease status.
22. Patients with a history of reactions/hypersensitivity to any of the following inhaled drugs or drugs o
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method