Comparative study of the efficacy and safety of Formoterol

Comparative study of the efficacy and safety of Formoterol, dry powder capsules for inhalation, 12 Âµg and Foradil, inhalation powder, capsules, 12 Âµg in patients with partially controlled bronchial asthmaâ??

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008277

Enrollment

136

Registered

2017-03-31

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- In patients with partially controlled bronchial asthma

Interventions

Intervention1: Trade name: Formoterol fumarate International nonproprietary name: Formoterol Pharmaceutical form: dry powder capsules for inhalation : A white to off-white powder in oblong capsules, w

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients 18 to 70 years of age inclusive. 2. Diagnosis of persistent asthma established according to the GINA guidelines (2015) not less than 6 months prior to the screening visit. 3. Need for combination bronchodilator therapy with long-acting beta-agonists in combination with inhaled glucocorticoids (IGC). 4. Asthma inadequately controlled with inhaled glucocorticoids (IGC) and short-acting beta-agonists (SABA) as on-demand therapy.

Exclusion criteria

Exclusion criteria: 1. Patients for whom starting maintenance therapy for asthma has to be selected. 2. Contraindications for treatment with inhaled glucocorticoids, hypersensitivity to formoterol, salbutamol, or to any other ingredient included in the formulation of the investigational medicinal product, reference product, or salbutamol. 3. Galactose intolerance, lactase deficiency, or glucose - galactose malabsorption. 4. Body mass index (BMI) > 35 kg/m2. 5. A diagnosis of chronic obstructive pulmonary disease (COPD) established according to the 2015 version of the GOLD guidelines.

Design outcomes

Primary

Measure	Time frame
Change in FEV1Timepoint: By the 2nd hour post inhalation during Visits 1 and 4.	—

Secondary

Measure	Time frame
Change in FEV1Timepoint: by the 2nd hour post inhalation during Visits 2, 3, and 4.;Changes in absolute PEFTimepoint: by Visits 2, 3, and 4.;Proportion of patients achieving asthma control (total ACQ-5 score 0.75)Timepoint: by Visit 4.;SF-36 (quality of life questionnaire) score changesTimepoint: by Visits 2 and 4.;Total ACQ-5 (asthma control questionnaire) score changesTimepoint: by Visits 2, 3, and 4.	—

Measure

Time frame

Change in FEV1Timepoint: by the 2nd hour post inhalation during Visits 2, 3, and 4.;Changes in absolute PEFTimepoint: by Visits 2, 3, and 4.;Proportion of patients achieving asthma control (total ACQ-5 score 0.75)Timepoint: by Visit 4.;SF-36 (quality of life questionnaire) score changesTimepoint: by Visits 2 and 4.;Total ACQ-5 (asthma control questionnaire) score changesTimepoint: by Visits 2, 3, and 4.

—

Countries

India, Russian Federation

Contacts

Public ContactDr Mangesh khadakban

Nexus Clinical Research (India) Ltd.

mangesh.khadakban@nexuscro.com9167243914

Outcome results

None listed

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