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

A randomized, double blind, prospective, single dose, placebo-controlled, cross over study to evaluate efficacy and safety of arformoterol inhalation solution (R,R-Formoterol) delivered by a nebulizer in subjects with chronic obstructive pulmonary disease (COPD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000179

Enrollment

211

Registered

2009-05-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Intervention1: Arformoterol Nebulized solution: 15 mcg/2ml Administered through a nebulizer, single dose over 6 minutes Control Intervention1: Placebo Nebulized solution: 2ml Administered through a ne

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects willing to give a written informed consent. 2. Subjects aged 35 years and above. 3. Subjects diagnosed with COPD as per GOLD guidelines (FEV1/FVC 0.70 L at screening visit. 4. Smoking history of at least 10 pack-years.

Exclusion criteria

Exclusion criteria: 1. 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. 6. 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). 8. 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

Design outcomes

Primary

Measure	Time frame
Mean difference in AUC FEV1Timepoint: From baseline to 12 hrs	—

Secondary

Measure	Time frame
FEV1 and FVC mean maximum responseTimepoint: From baseline to 12 hours;Mean difference in AUC FVCTimepoint: from baseline to 12 hours;No. of subjects with > 10 % increase in FEV1Timepoint: -;Time to maximum responseTimepoint: From baseline to 12 hours;Time to onset of response (defined as increase in FEV1 by 10%)Timepoint: From baseline to 12 hours	—

Countries

India

Contacts

Public ContactDr Sundeep Salvi

Cipla Ltd.

jgogtay@cipla.com022-23025412

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026