Clinical trial NCT04446637: 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
Official title: Comparison of Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination Delivered Via pMDI and Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol in Patients With Stable Moderate-Severe-Very Severe Chronic Obstructive Pulmonary Disease (COPD).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, ipratropium, levosalbutamol, levalbuterol, salbutamol, albuterol, MDI
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, single day, noninferiority study
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: FEV1 AUC (0-8h)
timeFrame: Baseline, 0 to 8 hours post-dose at treatment day
Secondary outcomes:
measure: FEV1 AUC (0-4h)
timeFrame: Baseline, 0 to 4 hours post-dose at treatment day
measure: FEV1 AUC (4-6h)
timeFrame: Baseline, 4 to 6 hours post-dose at treatment day
measure: FEV1 AUC (6-8h)
timeFrame: Baseline, 6 to 8 hours post-dose at treatment day
measure: FVC AUC (0-4h)
timeFrame: Baseline, 0 to 4 hours post-dose at treatment day
measure: FVC AUC (4-6h)
timeFrame: Baseline, 4 to 6 hours post-dose at treatment day
measure: FVC AUC (6-8h)
timeFrame: Baseline, 6 to 8 hours post-dose at treatment day
measure: FVC AUC (0-8h)
timeFrame: Baseline, 0 to 8 hours post-dose at treatment day
measure: Change From Baseline in FEV1 and FVC within the first 15 minutes after dosing
timeFrame: Baseline, 0 to 15 minutes post-dose at treatment day
measure: Mean Maximum Change From Baseline in FEV1 and FVC within the first 2 hours after dosing
timeFrame: Baseline, 0 to 2 hours post-dose at treatment day
measure: Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours
timeFrame: Baseline, 0 to 8 hours post-dose at treatment day
measure: The Time to Onset of Bronchodilator Response
timeFrame: Baseline, 0 to 8 hours post-dose at treatment day
measure: The Time to Maximum Effect
timeFrame: Baseline, 0 to 8 hours post-dose at treatment day
measure: Duration of Bronchodilator Response
timeFrame: Baseline, 0 to 8 hours post-dose at treatment day
measure: Evaluation of Safety (physical examination, numbers of adverse reactions and abnormal laboratory values or ECG related to treatment)
timeFrame: Baseline, 0 to 24 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Cukurova University Faculty of Medicine, Chest Diseases Department Adana - Turkey
name: Ismail Hanta, Professor Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sureyyapasa Training and Research Center for Chest Diseases and Thoracic Surgery, Maltepe, Istanbul - Turkey
name: Hakan Gunen, Professor Doctor
role: PRINCIPAL_INVESTIGATOR
References: