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

Neutec Ar-Ge San ve Tic

Status and phase

Withdrawn

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI

Drug: Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI

Study type

Interventional

Funder types

Industry

Identifiers

NCT04446637

NEU-01.19

Details and patient eligibility

About

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 inhalations) plus Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination in Patients with stable moderate-severe-very severe COPD.

Sex

All

Ages

40 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.