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Inhaled Budesonide for Prevention of Acute Mountain Sickness

Inhaled Budesonide for Prevention of Acute Mountain Sickness: A Single Center, Randomized, Double-Blind, Controlled, Prospective Trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-PRC-13003296
Enrollment
Unknown
Registered
2013-06-29
Start date
2013-06-30
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute mountain sickness

Interventions

Inhaled Budesonide empty bottle,the same dosage as Inhaled Budesonide.
Oral Dexamethasone:Oral Dexamethasone 4mg BID
Inhaled Budesonide empty bottle, the same dosage as Inhaled Budesonide.
Placebo:Oral placebo,the same dosage as dexamethasone
Inhaled Budesonide:Inhaled Budesonide 200ug BID
Oral placebo, the same dosage as dexamethasone.

Sponsors

Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Third Military Medical University, Chongqing, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 35 years, including 18 and 35 years;2. People acutely ascending to high altitude. The gender ratio depends on actual situation;3. Before assessment, all subjects must be voluntary and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects with high altitude exposure or preconditioning intervention history within the past 6 months; 2. Subjects with psychological or neurological disorder; 3. Subjects who cannot take the drugs in our trial because of allergic history or other reasons; 4. Subjects with bad compliance; 5. Subjects with serious illnesses; 6. Subjects with other conditions which are not appropriate for our trial.

Design outcomes

Primary

MeasureTime frame
Lake Louise Score;

Secondary

MeasureTime frame
Heart Rate;blood pressure;oxygen saturation;blood biochemistry;ECG;UCG;pulmonary function;Neurobehavioral Core Test Battery;vascular endothelial function;sleep quality;SCL-90;

Countries

China

Contacts

Public ContactHuang Lan
huanglan260@yahoo.com.cn+86 13808398102

Outcome results

None listed

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