Dry powder for inhalation dosed in patients with uncontrolled and partially controlled asthma

Phase 3

Completed

• Conditions: Health Condition 1: null- Uncontrolled and partially controlled asthma.

• Registration Number: CTRI/2016/02/006632
• Lead Sponsor: Rus Biopharm LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1.Male and female patients, aged from 18 to 70 years;

2.Written informed consent, obtained from the patient before any procedure related to the study;

3.Diagnosis of persistent asthma, established according to the GINA guidelines, version 2009, at least 6 months prior to the screening visit;

4.Partially controlled and uncontrolled BA (GINA, 2009).

5.Patients, who are indicated the use of a combination of long-acting beta2-adrenoceptor agonists (LABA) and glucocorticosteroids in form of inhalations.

6.Daytime symptoms of BA > 1 times a day;

7.Night symptoms of BA > 1 times per week;

8.Forced expiratory volumes per 1 sec. (FEV1) and peak expiratory flow rates (PEFR) in the range of 60 to 80% of age norms;

9.Reversibility of obstruction in tests with short-acting β2-agonists > 12%;

10.Daily bronchial lability > 30%;

11.Patients should use stable basic therapy of bronchial asthma with inhaled glucocorticosteroids + long-acting β2-agonists for at least 3 months prior to the screening visit. The average stable dose of inhaled glucocorticosteroids is determined as the dose of budesonide or equivalent drug from >= 400 µg to <= 800 µg.

12.Daily requirement in short-acting β2-agonists of not more than 8 inhalations per day for 2 consecutive days. During the study combined preparations, containing M-cholinoblockers and short-acting β2-agonists (e.g., berodual), must be replaced with short-acting β2-agonists;

13.Patients with of asthma control test scores under the ACT questionnaire of 19 and less;

14.Patients with total scores under the Asthma Control Questionnaire (ACQ) of more than 1.5;

15.Willingness to cooperate when performing study procedures.

16.Negative pregnancy test.

Exclusion Criteria

1.Pregnant or lactating women or all women physiologically capable of becoming pregnant, except those that fall under the following definition of postmenopausal women: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with the documented serum FSH level > 40 mIU/ml, or using one or more of the following acceptable methods of contraception; surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implant, patch, oral), double barrier methods (any dual combination of the following methods: intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).

2.Significant seasonal variation of bronchial asthma or bronchial asthma that occurs only during periodic exposure to allergens or chemical sensitizers;

3.History of bronchial asthma with almost fatal outcome (e.g., unstable bronchial asthma, hospitalizations due to asthma exacerbation in the intensive therapy unit with the application of intubation);

4.Diagnosis of COPD, established under the current version of GOLD guidelines, version 2009;

5. Exacerbation of bronchial asthma within 4 weeks prior to the screening visit, requiring the use of system glucocorticosteroids and hospitalizations (more than 24-hour hospital stay);

6.Frequent exacerbations of asthma: over 4 exacerbations 52 weeks before inclusion in the study;

7.Frequent night awakenings: more than 3 times a week;

8.Large requirement in short-acting β2-agonists of not more than 8 inhalations per day for 2 consecutive days.

9.Application of mast cell stabilizers, cholinoblockers, methylxanthines, antileukotriene and anti-IgE-drugs for the treatment of bronchial asthma;

10.Lower respiratory tract infection within 1 month before screening visit;

11.History of mucoviscidosis (fibrocystic disease, cystic fibrosis), bronchiectasis or alpha-1 antitrypsin deficiency;

12.Diagnosis of restrictive pulmonary process;

13.Patients, receiving oral or parenteral glucocorticosteroids in previous 2 months before screening visit (3 months for parenteral corticosteroids of prolonged action);

14.Conditions, requiring the use of systemic glucocorticosteroids.

15.Intolerance or contraindications to the treatment with β2-agonists and/or inhalation corticosteroids or allergy to any component of the investigated pharmacotherapy;

16.Receiving investigational medicinal product within 1 month before screening visit;

17.The presence of significant medical history and/or treatment of cardiac, renal, neurologic, hepatic, endocrine diseases or the presence of any abnormalities in laboratory indicators that can serve as an indicators of a significant disease that may affect patientâ??s safety, compliance, or assessment of the study, require the use of banned drugs, according to the investigator.

18.Cancer or a history of cancer within 5 years;

19.Smoking patients or ex-smokers, who smoked more than 10 pack-years and quitted smoking less than 1 year prior to inclusion in the study. (Pack-year: number of cigarettes, smoked per day, multiplied by the number of years of smoking/20);

20.Known or suspected QTc interval lengthening (QT corrected) > 0.44 sec;

21.Hereditary lactase deficiency, lactose intolerance or glucose-galactose malabsorption;

22.Participation in other clinical trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified