A clinical study to assess the efficacy and safety of Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation in patients with Chronic Obstructive Pulmonary Disease

Phase 4

Completed

• Conditions: Chronic obstructive pulmonary disease, unspecified,

• Registration Number: CTRI/2023/03/050717
• Lead Sponsor: Zydus Healthcare Limited

Brief Summary

A prospective, single-arm, multicentre, phase IV clinical trial to assess the efficacy and safety of Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg in patients with Chronic Obstructive Pulmonary Disease. With the primary objective of this clinical study is to evaluate the efficacy and safety of fixed dose combination of Glycopyrronium, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg in patients with Chronic Obstructive Pulmonary Disease.A total of 200 patients of COPD at geographically distributed centres in India will be enrolled in this clinical trial to evaluate the efficacy and safety of fixed dose combination of Glycopyrronium, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg.In this study, the patients with moderate to severe COPD receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) will be screened (visit 1) within 3 days prior to their enrolment. The eligible patients will then be enrolled at baseline visit (visit 2, day 0). After enrolment, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 3), week 8 (visit 4) and week 12 (visit 5). This will be a single arm study and all the enrolled patients will be given the fixed dose combination of Glycopyrronium, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg to be taken in a dose of two inhalations twice daily (two inhalations in the morning and two inhalations in the evening) by the oral inhalation route.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-31
• Study Completion: 2023-08-14
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients of either sex between 40-65 years of age (both inclusive) 2.
• Patients who are current/ex-smokers 3.
• Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit: o Post-bronchodilator FEV1/FVC ratio < 0.7; o Post-bronchodilator FEV1, ≥ 30% to < 80% predicted 4.
• COPD Assessment Test (CATTM) score ≥ 10 even after receiving at least two inhaled maintenance therapies (LABA+ LAMA or LABA + ICS) for at least 4 weeks at the time of screening 5.
• Written informed consent from the patient 6.
• Patients literate enough to fill the diary card and willing to comply with the protocol requirements.

Exclusion Criteria

• Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
• Patients with known α1 antitrypsin deficiency 3.
• Patients diagnosed with COVID-19 in last 3 months 4.
• COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period 5.
• Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period 6.
• Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period 7.
• Patients who required long-term oxygen therapy (≥12hours/day) within 4 weeks prior to the screening or during the screening period 8.
• Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention 9.
• Patients with known hypersensitivity to formoterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents 10.
• Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 11.
• Patients with hepatic dysfunction (serum transaminases ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl) at screening 12.
• Patients with continuing history of alcohol and/or drug abuse 13.
• Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 14.
• Any other reason for which the investigator feels that the patient should not participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in trough FEV1 at week 4 and week 12 as compared to baseline	week 4 and 12

Secondary Outcome Measures

Name	Time	Method
â— Change in CATTM score at week 4, 8 and 12 as compared to baseline	â— Change in trough FVC at week 4 and week 12 as compared to baseline

Trial Locations

Locations (4)

Aatman Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Govt. Medical College Govt.General Hospital, Srikakulam; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Jeevan Rekha Hospital; 🇮🇳 Belgaum, KARNATAKA, India

New Leelamani Hospital; 🇮🇳 Dehat, UTTAR PRADESH, India

Aatman Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Chintan B Patel

Principal investigator

9825182251

cr.aatman@gmail.com