A clinical study to evaluate efficacy and safety of arformoterol inhalation solution delivered by a nebulizer in subjects with chronic obstructive pulmonary disease (COPD).

Phase 3

Completed

Brief Summary: This study is a multi-centre randomized, double blind, single dose, placebo-controlled, cross over study to evaluate efficacy and safety of arformoterol inhalation solution delivered by a nebulizer in subjects with chronic obstructive pulmonary disease (COPD). The study was carried out in ten centers in India. Two hundred and twelve patients were enrolled into the study. The primary endpoint is a mean difference in AUC FEV1 from baseline to 12 hrs, and the secondary endpoints would be mean difference in AUC FVC from baseline to 12 hours,.FEV1 and FVC mean maximum response. Time to onset of response (defined as increase in FEV1 by 10%), No. of subjects with > 10 % increase in FEV1, time to maximum response.

Recruitment & Eligibility

Inclusion Criteria

Subjects willing to give a written informed consent.
Subjects aged 35 years and above.
Subjects diagnosed with COPD as per GOLD guidelines (FEV1/FVC < 70% and FEV1 < 80% predicted) with FEV1 <65% of predicted normal value and >0.70 L at screening visit.
Smoking history of at least 10 pack-years.

Exclusion Criteria

Subjects requiring continuous supplemental oxygen therapy.
The use of supplemental oxygen, not exceeding 2 L/minute, at night time only and/or only during exercise is allowed.2. Change in dose or type of any medications for COPD within 14 days prior to the screening visit.3. History of asthma or any chronic respiratory disease other than COPD.4. Hospitalization for pulmonary exacerbation within the past 2 months.5. Life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days.
History of lung resection of more than one full lobe.7. Using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers).
Absolute Blood eosinophil count >600 cells/c mm of blood.9. Have a known sensitivity to formoterol, ipratropium, salbutamol, levosalbutamol or any of the excipients contained in any of these formulations.10.
Treatment with any other investigational drug in last 30 days prior to screening.

Primary Outcome Measures

Name	Time	Method
Mean difference in AUC FEV1	From baseline to 12 hrs

Secondary Outcome Measures

Name	Time	Method
Mean difference in AUC FVC	from baseline to 12 hours
No. of subjects with > 10 % increase in FEV1	-
FEV1 and FVC mean maximum response	From baseline to 12 hours
Time to maximum response	From baseline to 12 hours
Time to onset of response (defined as increase in FEV1 by 10%)	From baseline to 12 hours

Locations (10): Allergy, Asthma & Chest Centre
🇮🇳
Mysore, KARNATAKA, India
Asthma Bhawan
🇮🇳
Jaipur, RAJASTHAN, India
Chest Research Centre
🇮🇳
Chennai, TAMIL NADU, India
Chest Research Foundation
🇮🇳
Pune, MAHARASHTRA, India
Dr. Narender Khippal Clinic
🇮🇳
Jaipur, RAJASTHAN, India
JSS Medical College Hospital
🇮🇳
Mysore, KARNATAKA, India
Karthik Polyclinic
🇮🇳
Coimbatore, TAMIL NADU, India
Kasturba Medical College & Hospital
🇮🇳
Madhav, India
Kovai Medical Centre and Hospital
🇮🇳
Coimbatore, TAMIL NADU, India
PSG Institute of Medical Science & Research
🇮🇳
Coimbatore, TAMIL NADU, India
Allergy, Asthma & Chest Centre
🇮🇳Mysore, KARNATAKA, India
Dr P A Mahesh
Principal investigator
mahesh1971in@yahoo.com