Effect of Salmetrol-Fluticason combination and Tiotropium on bronchial anthracofibrosis

Effect of Salmetrol-Fluticason combination and Tiotropium on clinical and physiological improvement of bronchial anthracofibrosis, a double blind randomized placebo controlled clinical trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201404072695N5

Enrollment

Registered

2014-12-28

Start date

2014-11-28

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Anthracosis. Coalworker pneumoconiosis

Interventions

Intervention 1: Drugs and their strength: The dosage of drugs are Salmetrol 25 µg- Fluticason 250 µg, 2 puff twice daily and Tiotropium 18 microgram once daily. The drugs will be covered which cannot

Treatment - Drugs

Drugs and their strength: The dosage of drugs are Salmetrol 25 µg- Fluticason 250 µg, 2 puff twice daily and Tiotropium 18 microgram once daily. The drugs will be covered which cannot be able to recog

Second phase: In the second phase, after evaluation for outcomes, each group will be treated with drugs and placebo of other group (cross over). For example the group treated with Salmetrol- Fluticaso

Third phase: In the third phase, after evaluation for outcomes, both groups will treat with both drugs of Salmetrol- Fluticason and Tiotropium for one month. At the end of this phase the subjects will

Eligibility

Sex/Gender

All

Age

25 Years to 110 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Dyspnea; Diffuse wheezing; Spirometetry impaiement either obstructive or restrictive; Bronchoscopic findings consistent with bronchial obstruction with anthracosis. Exclusion criteria: Smoking; Recent treatment; Phlegm in favor of pneumonia; Sever respiratory distress required systemic corticosteroid therapy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Quality of life. Timepoint: before treatment. Method of measurement: CAT questionnaire.	—

Secondary

Measure	Time frame
MMEF (Maximal mid expiratory flow). Timepoint: One month after treatment. Method of measurement: Spirometry.;Cough. Timepoint: One month after treatment. Method of measurement: Cough standard scale.;Wheezing. Timepoint: One month after treatment. Method of measurement: Physical exam.;FEV1 (Forced expiratory volume in one second). Timepoint: Before and after each trial. Method of measurement: Spirometry.;Dyspnea. Timepoint: Before and after each three phase of treatment. Method of measurement: MMRC questionnaire.	—

Measure

Time frame

MMEF (Maximal mid expiratory flow). Timepoint: One month after treatment. Method of measurement: Spirometry.;Cough. Timepoint: One month after treatment. Method of measurement: Cough standard scale.;Wheezing. Timepoint: One month after treatment. Method of measurement: Physical exam.;FEV1 (Forced expiratory volume in one second). Timepoint: Before and after each trial. Method of measurement: Spirometry.;Dyspnea. Timepoint: Before and after each three phase of treatment. Method of measurement: MMRC questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Mirsadraee

Islamic Azad University of Mashhad

majidmirsadraee@mshdiau.ac.ir, majidmirsadraee@yahoo.com+98 51 1882 0712

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 26, 2026