A Clinical Trial to study the efficacy of Mannitol Capsules for Oral Inhalation manufactured by Ajanta Pharma Limited, as a bronchial provocation test to measure bronchial hyperresponsiveness verses Hypertonic (4.5 %) Saline in people both with and without sign and symptoms of asthma.

An operator blinded, randomised, comparator multicentric study to evaluate the efficacy and safety of inhaled dry powder mannitol as a bronchial provocation test for airway hyperresponsiveness.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000848

Enrollment

200

Registered

2010-02-16

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- Asthmatic and non-asthmatic Patients Health Condition 2: J709- Respiratory conditions due to unspecified external agent

Interventions

Intervention1: Mannitol Capsules for Oral Inhalation: The FEV1 will be measured 60 seconds after each dose of mannitol (5, 10, 20, 40, 80, 160, 160, 160 mg). Total 3 challenges at interval of a week C

Eligibility

Inclusion criteria

Inclusion criteria: 1) For asthmatic subjects: Active signs and symptoms of asthma. 2) For non-asthmatic subjects: No clinical diagnosis of asthma or experience of signs and symptoms suggestive of asthma. 3) Able to perform repeatable spirometry 4) Patient willing to give informed consent to participate in this study in accordance with ICH GCP guidelines and local regulatory requirements. 5) Baseline FEV1 greater than 70% of normal predicted values for asthmatic subjects OR greater than 80% of normal predicted values for non-asthmatic subjects.

Exclusion criteria

Exclusion criteria: 1) Pregnant and nursing women 2) Ocular or abdominal surgery in the three months 3) Patients who have participated in another trial in the previous 4 weeks 4) Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications. 5) Intolerance to mannitol or salbutamol 6) Previous admission to Intensive Care for asthma in the last two years 7) Oral / parenteral corticosteroids (in the two weeks prior to study enrolment)

Design outcomes

Primary

Measure	Time frame
Reduction in FEV1Timepoint: 60 seconds after each dose of mannitol (5, 10, 20, 40, 80, 160, 160, 160 mg) or each exposure to Hypertonic Saline (0.5, 1.0, 2.0, 4.0, 8.0 minutes)in 1st challenge, 2nd challenge and 3rd challenge	—

Secondary

Measure	Time frame
Comparison of safety of Mannitol Capsules for Oral Inhalation and Hypertonic (4.5 %) Saline as a bronchial provocation test to measure bronchial hyperresponsiveness in people both with and without sign and symptoms of asthma.Timepoint: 1st challenge(on admission to the study), 2nd challenge (1st week) and 3rd challenge(2nd week)	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

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