A clinical trial to study of Budesonide/Formeterol fumarate/Tiotropium bromide fixed dose combination in MDI for the treatment of the patients with Chronic Obstructive Pulmonary Disease (COPD)

A phase III, open-label, non-randomized, single arm study to assess the efficacy and safety of a Budesonide/Formeterol fumarate/Tiotropium bromide fixed dose combination in MDI for the treatment of the patients with Chronic Obstructive Pulmonary Disease (COPD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000785

Enrollment

120

Registered

2010-02-17

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: Budesonide/Formeterol fumarate/Tiotropium bromide fixed dose combination in MDI: Two puffs, once daily for six weeks Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: ? (FEV1/FVC <70%, 30% &#8804; FEV1 < 80% predicted) . ? Patients with Signs & symptom of Chronic Obstructive Pulmonary Disease. &#61656; Cough &#61656; Sputum (mucus) production for at least three month &#61656; Dyspnea ( shortness of breath ,gasping ) &#61656; Wheezing (a whistling or squeaky sound on expiration) &#61656; Chest tightness

Exclusion criteria

Exclusion criteria: &#61656; Known hypersensitivity to Budesonide, Formeterol fumarate, Tiotropium bromide &#61656; History of Asthma &#61656; Pregnancy or lactation

Design outcomes

Secondary

Measure	Time frame
Based on the following variables. 1. Adverse events 2. Use of rescue medication Change in the pathological investigations Timepoint: Six Weeks	—

Primary

Measure	Time frame
Changes in following variables: 1. Force Expiratory Volume (FEV1) 2. Peak Expiratory Flow (PEF) 3. Vital Capacity (VC ) 4. Quality Life Questionnaires (QOL) Timepoint: Six Weeks	—

Countries

India

Contacts

Public ContactDr Alok Chaturvedi

alokchaturvedi@lupinpharma.com022-66402200

Outcome results

None listed

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