Clinical study to assess the effect of QVA149 on cardiac functions in COPD patients

Phase 1

• Conditions: chronic obstructive pulmonary disease (COPD); MedDRA version: 19.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004680-21-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-26
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. Male or female subjects, aged = 40 years, giving written Informed Consent and who are willing and capable to comply with all study procedures.
3. Patients with stable COPD according to the current GOLD guidelines (GOLD 2014).
4. Patients with airflow limitation indicated by a post-bronchodilator FEV1 <80% of the predicted normal value and a post-bronchodilator FEV1/FC<0.7 at Visit 3. Post-bronchodilator refers to within 10-15 min after inhalation of 400 µg (4x100 µg) of salbutamol.
5. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
6. Hyperinflated patients with RVol>135% predicted as measured at Visit 3, before intake of salbutamol.

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

1. Pat. with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof
• anticholinergics
• long and short acting beta-2 agonists
• sympathomimetic amines
• lactose or any of the other excipients
2. Pat. with a history of long QT syndrome or whose QTcF (Fredericia method) measured at Visit 3 is prolonged (>450 ms for males and >470 ms for females). These patients should not be re-screened.
3. Pat. who have a clinically significant abnormality on the ECG at Visit 3, who in the judgment of the investigator would be at potential risk if enrolled into the study. These patients should not be re-screened.
4. Pat. who have clinically significant cardiovascular abnormalities, which could interfere with the assessment of the study treatment
5. Pat. with a known history or current atrial fibrillation to be confirmed by ECG at Visit 3.
6. Pat. with pacemaker or bypass.
7. Pat. with a mean sitting systolic blood pressure >160 mmHg and/or mean sitting diastolic blood pressure >90 mmHg at Visit 3. These pats. will be permitted to be rescreened after having achieved controlled disease status following initiation or intensification of antihypertensive therapy. Re-screening can start at Visit 2, 4 weeks after change of antihypertensive medication.
8. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to history of hepatic disease, renal disease, hematological disease, neurological and psychiatric disease, endocrine disease or pulmonary disease other than COPD (including but not confined to tuberculosis, bronchiectasis, cystic fibrosis, pulmonary hypertension, sarcoidosis, interstitial lung disease or lung fibrosis).
9. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
10. Pat. with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or severe renal impairment (GFR<30 mL/min/1.73 m2) including those with end-stage renal disease requiring dialysis or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered.
11. Pat. with Type I or uncontrolled Type II diabetes.
12. Pat. with active/ clinical history of asthma.
13. Pat. unable to undergo MRI scans, including claustrophobia or presence of any metal objects within the patient, preventing from MRI scan. A separate MRI patient informed consent form including MRI safety will be signed by the patient before each MRI exam.
14. History of lower respiratory tract infection within four weeks prior to Visit 2 and between Visit 2 and Visit 4. These patients will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection and can re-start at Visit 2.
15. History of one COPD exacerbation that required treatment with antibiotics, systemic steroids or hospitalization within 3 months prior to Visit 2.
16. More than one COPD exacerbation that required treatment with antibiotics, systemic steroids or hospitalization within 6 months prior Visit 2.
17. Pat. who develop a COPD exacerbation between Visit 2 and Visit 4 will not be eligible but will be permitted to be

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified