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Suitability of tiotropium and formoterol combinations in respiratory condition called COPD (Chronic Obstructive Pulmonary Disease)

Acute effects of Tiotropium alone and in combination with Formoterol in patients with COPD: Comparison of three regimens

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/07/003827
Enrollment
60
Registered
2013-07-23
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 patients without other associated Comorbidities

Interventions

Intervention1: Tiotropium 18 microgram and Formoterol 12 microgram: Fixed dose combination of Titropium 18 microgram plus Formoterol 12 microgram in the morning and Formoterol 12 microgram in the even

Sponsors

Mohammed Imran
Lead Sponsor
Vallabh Bhai Patel Chest Institute
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged 35 years and above. 2. COPD diagnosed according to GOLD guidelines. 3. Patient with mild to moderate patients would be taken. 4. Smoking greater than or equal to 10 pack years.

Exclusion criteria

Exclusion criteria: 1. Current or past history of clinically relevant asthma. 2. Need for long term oxygen therapy. 3. Exacerbation of COPD in previous 4 weeks. 4. Radiological or clinical evidence of other pulmonary disease. 5. Known case of chronic angle glaucoma or Benign hyperplasia of prostate. 6. Pregnant and lactating women. 7. History of coexistent systemic disease.

Design outcomes

Primary

MeasureTime frame
1. Improvement or change in FEV1 and FVC at each assessment scheduled time till 24 hours. 2. Improvement in dyspnoea measured at each assessment scheduled time till 24 hours.Timepoint: 1. Improvement or change in FEV1 and FVC at each assessment scheduled time till 24 hours. 2. Improvement in dyspnoea measured at each assessment scheduled time till 24 hours.

Secondary

MeasureTime frame
1. Rescue therapy with salbutamol 2. Adverse events 3. Sleep disturbanceTimepoint: As and when recorded

Countries

India

Contacts

Public ContactMohammed Imran
skchhabra@lycos.com

Outcome results

None listed

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