A research study to compare two treatments for treating a respiratory disease known as asthma-COPD overlap syndrome (ACOS).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

1. Male or female subjects aged = 40 years at Screening visit.
2. Adequate contraception:
- Female subjects of child bearing potential (less than 1 year post-menopausal) must have a negative urine pregnancy test prior to first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of birth control throughout the study such as sterilisation, implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence, where this is line with the preferred and usual lifestyle of the subject or vasectomised partner.
Note: Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for duration of study, and withdrawal are not acceptable methods of contraception).
- Male subjects with a partner of child-bearing potential must be willing to use adequate and highly effective methods of birth control throughout the study (as defined above).
3. Diagnosis of fixed airflow obstruction with elevated eosinophils /ACOS as evidenced by:
- Chronic respiratory symptoms e.g. wheezing, dyspnoea, especially exertional dyspnoea) for at least 6 months prior to Screening.
- Smoking history of = 10 pack years (equivalent to, for example, 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years).
- Post-bronchodilator FEV1 / FVC ratio < 0.7 and post bronchodilator FEV1 >30 and <=60% predicted normal measured at visit 1 (GLI 2012).
- Evidence of eosinophilic inflammation demonstrated by eosinophils in induced sputum of =3% at Visit 1 (assessed at central laboratory) and Visit 3 (assessed at local laboratory).
4. Subjects symptomatic at Visit 1 (CAT =10) despite currently receiving treatment with either LAMA or LABA monotherapy or LAMA + LABA as a combination inhaler or separate inhalers.
5. Documented history of = 1 moderate or severe respiratory disease exacerbations (requiring treatment with systemic corticosteroids and/or antibiotics and/or hospitalisation) in the previous year.
6. Willing and able to replace current therapy for obstructive lung disease with study medication.
7. Able to demonstrate correct use of a BAI, Breezehaler and pMDI.
8. Willing and able to attend all study visits and complete study assessments.
9. Able to provide signed informed consent.
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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. Respiratory disease exacerbation between 4 weeks prior to screening and Visit 3 (Randomisation).
2. Previous treatment with ICS.
3. Documented evidence of a1-antitrypsin deficiency.
4. Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
5. Use of long-term oxygen therapy (LTOT) at least 12 hours daily or mechanical ventilation.
6. Chest X-ray or CT scans performed prior to screening which reveal evidence of clinically significant abnormalities reflective of active disease not believed to be due to COPD.
7. Evidence of uncontrolled cardiovascular disease.
8. Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease.
9. Current malignancy or a previous history of cancer which has been in remission for < 5 years (basal cell or squamous cell carcinoma of the skin which has been resected is not excluded).
10. Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
11. Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study.
12. Known or suspected history of drug or alcohol abuse in the last 2 years.
13. Requiring treatment with any of the prohibited concomitant medications.
14. Known or suspected hypersensitivity or contraindication to any of the study drugs or excipients.
15. Received an investigational drug within 30 days of the Screening.
16. Received a systemic corticosteroid within 30 days of the Screening visit.

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

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