COPD Clinical Trial
Official title:
A Phase IV, Randomized, Double-blind, Placebo-controlled, Multicenter, Exploratory, Single-dose Crossover Study With Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Verified date | May 2013 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in moderate-severe COPD patients with breathing symptoms to assess time to patient's perception of onset of effect.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening - Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and: - Smoking history of at least 10 pack-years - Post-bronchodilator forced expiratory volume in 1 second (FEV1) = 70% and = 40% of the predicted normal value - Post-bronchodilator FEV1/FVC (forced vital capacity) < 70% - Breathing symptoms that interfere with daily activities Exclusion Criteria: - Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening - Patients who have had a respiratory tract infection within 6 weeks prior to screening - Patients who require oxygen therapy for chronic hypoxemia, are receiving bronchodilators or other medications for COPD that are dosed once daily, are unable to follow instruction on rescue albuterol use during the study, or are at risk deterioration of COPD with study procedures. Patients with concomitant pulmonary disease - Patients with a history of asthma - Patients with uncontrolled diabetes mellitus - Any patient with lung cancer or a history of lung cancer - Patients with a history of certain cardiovascular co-morbid conditions Other protocol-defined inclusion/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Novartis Investigative Site | Charlotte | North Carolina |
United States | Novartis Investigative Site | Columbus | Ohio |
United States | Novartis Investigative Site | Fullerton | California |
United States | Novartis Investigative Site | Raleigh | North Carolina |
United States | Novartis Investigative Site | St. Charles | Missouri |
United States | Novartis Investigative Site | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time (in Minutes) to Patient's Perception of Onset of Effect | Defined as the first time point that the patient responds "yes" to the following self-administered question: "I feel that the drug is working in improving my breathing?" |
5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06000696 -
Healthy at Home Pilot
|
||
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT04105075 -
COPD in Obese Patients
|
||
Recruiting |
NCT05825261 -
Exploring Novel Biomarkers for Emphysema Detection
|
||
Active, not recruiting |
NCT04075331 -
Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
|
Phase 2/Phase 3 | |
Terminated |
NCT03640260 -
Respiratory Regulation With Biofeedback in COPD
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|
||
Withdrawn |
NCT04210050 -
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
|
N/A | |
Terminated |
NCT03284203 -
Feasibility of At-Home Handheld Spirometry
|
N/A | |
Recruiting |
NCT06110403 -
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06040424 -
Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Recruiting |
NCT04868357 -
Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program
|
N/A | |
Completed |
NCT01892566 -
Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
|
N/A | |
Completed |
NCT04119856 -
Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD
|
N/A | |
Completed |
NCT04485741 -
Strados System at Center of Excellence
|
||
Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
Recruiting |
NCT04860375 -
Multidisciplinary Management of Severe COPD
|
N/A |