A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP 24 WEEK PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY WITH A 28 WEEK LONG TERM EXTENSION, OF NEBULIZED FLUTICASONE PROPIONATE (FP) /FORMOTEROL FUMARATE (FF) COMBINATION COMPARED WITH FP AND FF MONOTHERAPY IN PATIENTS WITH COPD

Not Applicable

• Conditions: -J449 Chronic obstructive pulmonary disease, unspecified; Chronic obstructive pulmonary disease, unspecified; J449

• Registration Number: PER-055-14
• Lead Sponsor: Mylan Pharma UK Ltd.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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 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 (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.

Exclusion Criteria

1)Current diagnosis of asthma.
2)Alpha-1 anti-trypsin deficiency.
3)Other chronic or active respiratory disorder (e.g. clinically significant bronchiectasis, pulmonary fibrosis, sarcoidosis, pneumoconiosis, active tuberculosis).
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. An AECOPD is defined as an acute event in the natural course of the disease warranting a change in the patient’s regular medication specifically to address the exacerbation event, characterized by:
a.worsening, beyond normal day-to-day variation, of two or more of the following major symptoms for at least two consecutive days: Dyspnea, Sputum volume, Sputum purulence
OR
b.worsening, beyond normal day-to-day variation, of any one major symptom outlined above plus any one of the following minor symptoms for at least two consecutive days: Sore throat, Colds (nasal discharge and/or nasal congestions), Fever without other cause, Increased cough, Increased wheeze
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 (maintenance program is permitted).
10)Clinically significant, abnormal chest X-ray at screening indicating an active/significant disease process other than COPD. If a prior chest X-ray 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 (0.460 seconds).
12)History within past 5 years of paroxysmal atrial fibrillation. Patients with continuous atrial fibrillation controlled with a rate control strategy (i.e., cardioselective β-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). Clinically significant abnormalities may include but are not limited to the following: left bundle branch block, Wolff-Parkinson-White syndrome, clinically significant arrhythmias (e.g., ventricular tachycardia).
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified