Chronic Obstructive Pulmonary Disease - COPD Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Incomplete Unbalanced, Crossover Study to Assess the Efficacy and Safety of Three Doses of Formoterol Fumarate in Pressair® Compared With Perforomist® Inhalation Solution (20 and 40 μg Open-label) in Moderate to Severe COPD Patients With Reversible Airway Disease.
Verified date | January 2018 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).
Status | Completed |
Enrollment | 132 |
Est. completion date | December 7, 2016 |
Est. primary completion date | December 7, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 130 Years |
Eligibility |
Inclusion Criteria: - Adult male or non-pregnant, non-lactating female patients aged =40. - Patients with a diagnosis of COPD (GOLD guidelines, 2016) for a period of at least 6 months prior to Visit 1. - Patients with moderate to severe stable COPD: post-bronchodilator FEV1 = 30% and <80% of the predicted normal and post-bronchodilator FEV1/FVC < 70% at Visit 1. - Patients with reversible airway obstruction defined as an increase in FEV1 of at least 12% and 200 mL over the baseline value after four inhalations of albuterol sulfate 108 µg via a pMDI at Visit 1. - Current or former-smokers, with a smoking history of = 10 pack-years. - Patients able to perform acceptable and repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria at Visit 1. - Patients eligible and able to participate in the study and who had signed an Informed Consent Form prior to initiation of any study-related procedures. Exclusion Criteria: - Patients with asthma. - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to Visit 1 or during the run-in period. - Patients hospitalized for a COPD exacerbation (an emergency room visit for longer than 24 hours is considered a hospitalization) within 3 months prior to Visit 1. - Clinically significant respiratory conditions other than COPD. - Patients who in the investigator's opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Visit 1. - Use of long-term oxygen therapy (= 15 hours/day). - Patients who do not maintain regular day/night, waking/sleeping cycles including night shift workers. - Clinically significant cardiovascular conditions. - Patients with uncontrolled Type I or Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled hypertension. - Patients with history of long QT syndrome or whose QTc (calculated according to Fridericia's Formula QTc=QT/RR1/3) > 470 ms as indicated in the centralized reading report assessed at Visit 1. - Patients with clinically significant abnormalities in the laboratory tests, ECG parameters (other than QTc) or in the physical examination at Visit 1 that might compromise patient safety. - Patients with a history of hypersensitivity reaction to an inhaled medication or any component thereof, including paradoxical bronchospasm. - Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention or symptomatic unstable prostate hypertrophy. - History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer. - Patients with any other serious or uncontrolled physical or mental dysfunction. - Patients with a history (within 2 years prior to screening) of drug and/or alcohol abuse that may prevent study compliance based on the Investigator judgment. - Patients unlikely to be cooperative or who cannot comply with the study procedures. - Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1. - Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication. - Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients. - Any other conditions that, in the investigator's opinion, might render the patient to be unsuitable for the study. - Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff), or patients employed by or relatives of the employees of the site or sponsor. - Previous randomization in the present study D6571C00002. |
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Boerne | Texas |
United States | Research Site | Celebration | Florida |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Clearwater | Florida |
United States | Research Site | DeLand | Florida |
United States | Research Site | Easley | South Carolina |
United States | Research Site | Gastonia | North Carolina |
United States | Research Site | Glendale | Arizona |
United States | Research Site | Greenville | South Carolina |
United States | Research Site | Killeen | Texas |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | Lawrenceville | Georgia |
United States | Research Site | Medford | Oregon |
United States | Research Site | Orlando | Florida |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Portland | Oregon |
United States | Research Site | Rock Hill | South Carolina |
United States | Research Site | Saint Louis | Missouri |
United States | Research Site | Spartanburg | South Carolina |
United States | Research Site | Tempe | Arizona |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Parexel |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment | To assess the bronchodilation of 3 doses of formoterol fumarate (6 µg, 12 µg and 24 µg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 µg). Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them. Note: Perforomist® 40 µg treatment periods lasted for 1 day only. Hence, was not included in the calculation. |
Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose | |
Secondary | Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment | To assess the bronchodilation of 3 doses of formoterol fumarate (6 µg, 12 µg and 24 µg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 µg and 40 µg). 6-hour serial spirometry was performed at Day 1 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose. | Day 1: zero time to 6 hours post-dose | |
Secondary | Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment | To assess the bronchodilation of 3 doses of formoterol fumarate (6 µg, 12 µg and 24 µg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 µg). 6-hour serial spirometry was performed at Day 7 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose Note: Perforomist® 40 µg treatment periods lasted for 1 day only. Hence, was not included in the calculation | Day 7: zero time to 6 hours post-dose | |
Secondary | Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment | To assess the bronchodilation of 3 doses of formoterol fumarate (6 µg, 12 µg and 24 µg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 µg). Trough value was defined as the mean of the 2 pre-dose measurements on Day 7. If 1 of the 2 measurements was missing, the non-missing measurement was used as the trough value. Note: Perforomist® 40 µg treatment periods lasted for 1 day only. Hence, was not included in the calculation. |
At baseline and Day 7 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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