A clinical trial to compare the efficacy and safety of two formulations of inhaled ipratropium bromide in patients chronic obstructive pulmonary disease (COPD).

A randomised, double-blind, double dummy, multicentre, parallel-group study comparing the efficacy and safety of the test HFA formulation of ipratropium bromide (Cipla Ltd., India) with the reference HFA formulation of ipratropium bromide (Boehringer Ingelheim, UK) in patients with mild or moderate chronic obstructive pulmonary disease (COPD)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/05/005793

Enrollment

395

Registered

2015-05-21

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: Ipratropium HFA pMDI: 2 puffs thrice daily for 12 weeks Control Intervention1: Ipratropium bromide HFA pMDI: 2 puffs thrice daily for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: COPD patients diagnosed according to GOLD criteria. Male or female subjects between 40-75 years of age inclusive. Pre bronchodilator FEV1 ï?³ 50% and <= 80% of predicted value. FEV1/FVC ratio pre-bronchodilator < 70% at screening. Smoking history of ï?³ 10 pack years. Patients must be able to effectively use the pMDI without a spacer . Subject or subjectâ??s legally acceptable representative is willing to sign informed consent document after the subject is provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug. COPD patients who require regular treatment with ipratropium bromide and who are treated with ipratropium bromide with or without Î²2-agonist inhalation.

Exclusion criteria

Exclusion criteria: Subjects with a history of asthma, allergic rhinitis, atopy or those who have a total eosinophil count greater than 600/ÂµL . Acute exacerbation requiring hospitalization or Emergency Department treatment or as judged by the investigator or any change in COPD therapy (other than inhalation of short-acting Î²2-agonists as relief medication), within the last 3 months of the screening visit. Use of systemic corticosteroids within the last 3 months of the screening visit . Subjects suffering from any serious uncontrolled medical conditions or any concomitant pulmonary disease. Clinically relevant respiratory infection requiring antibiotics, as judged by the investigator, within the last 3 months prior to the screening visit. Females who are pregnant or lactating.

Design outcomes

Primary

Measure	Time frame
Change in FEV1 at 90 min post dose on day 85Timepoint: Pre dose and at 90 minutes post dose	—

Secondary

Measure	Time frame
Overall symptom scores Total daily use of inhaled rescue medication Timepoint: Baseline and after 4,8 and 12 weeks after randomisation	—

Countries

India

Contacts

Public ContactDr S Purandare

Cipla Ltd

jgogtay@cipla.com

Outcome results

None listed

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