Status:
WITHDRAWN
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
Lead Sponsor:
Neutec Ar-Ge San ve Tic A.Ş
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-120 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare acute bronchodilator effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI and Salbutamol 100 mcg Inhaler (2 inhalatio...
Eligibility Criteria
Inclusion
- Female and male patients aged ≥40 years diagnosed with symptomathic stable moderate-severe-very severe COPD: post-bronchodilator FEV1/FVC \<70% predicted and a post-bronchodilator FEV1 \<80% predicted at screen visit.
- Group B COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: 0-1 (not leading to hospital admission)
- Group C COPD CAT: \<10 or mMRC: 0-1 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)
- Group D COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)
- Current or ex-smokers with a smoking history of at least 10 pack-years
- Patients who have no exacerbation within the last 4 weeks
- Female patients who use effective contraception
- Patients who have a capability to communicate with investigator
- Patients who accept to comply with the protocol
- Patients who sign written informed consent form
Exclusion
- History of hypersensitive to anticholinergics or SABAs
- History of COPD exacerbation or lower respiratory track infection that required treatment with antibiotic, oral or parenteral corticosteroid within the last 4 weeks prior the screening visit or during the run-in/wash-out period or history of respiratory tract infection that required treatment with antibiotic within the last 14 days prior the screening visit.
- Hospitalization due to COPD or pneumonia within the last 3 mounts prior the screening visit
- Use of oral corticosteroid at unstable dosages (i.e. \<6 weeks on a stable dose of prednisone)
- SGOT (serum glutamic oxaloacetic transaminase) \>80 IU/L, SGPT (serum glutamic pyruvic transaminase) \>80 IU/L, bilirubin \>2.0 mg/dL or creatinine \>2.0 mg/dL
- History of asthma, significant chronic respiratory diseases (i.e., significant bronchiectasis, interstitial lung diseases, etc.) other than COPD or presence of disease that may be serious and/or potentially affect results of the study.
- Initiation of an inhaled steroid or change in dose within \<6 weeks prior the screening visit
- Use of beta-blocker, monoamine oxidase (MAO) inhibitor or tricyclic antidepressant within the last 30 days prior the screening visit
- Recent (within ≤1 year prior the screening visit) history of heart attack, heart failure, acute ischemic heart disease or presence of serious cardiac arrhythmia requiring drug treatment
- Regularly use of daytime CPAP (continuous positive airway measure) oxygen therapy for longer than 1 hour per day
- Initiation of pulmonary rehabilitation within the 3 months prior the screening visit
- History of lung volume reduction surgery
- Drug or alcohol abuse
- Presence of active tuberculosis
- History of atopy or allergic rhinitis
- History of cancer within the last 5 years
- Attenuated live virus vaccination within the last 2 weeks prior the screening visit or during the run-in/wash-out period
- Pregnancy or lactation
- Presence of known symptomatic prostatic hypertrophy requiring treatment
- Presence of known narrow-angle glaucoma requiring treatment
- Currently participating in another clinical trial or treatment with another investigational study drug within the last month or 6-half-lives, whichever is longer.
Key Trial Info
Start Date :
September 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04446637
Start Date
September 3 2021
End Date
September 3 2022
Last Update
September 13 2021
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